Clinical trial NCT02769065: Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants
Official title: A Phase 1 Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Oral Doses of TAK-071 in Healthy Subjects and Subjects With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability and Food Effect of TAK-071 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer Disease
Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).

Detailed description: TAK-071 was being tested to find a safe and well-tolerated dose in healthy participants (non-Japanese and Japanese) and participants with MCI or mild AD (non-Japanese).

The study enrolled 179 participants. The study consisted of 4 parts: Single-rising dose (SRD) part (Cohorts 1-6, and 18-22), multiple-rising dose (MRD) part (Cohorts 7-15), Cohort 16 with 2-arm parallel design, and Cohort 17 relative bioavailability and food effect 3 period crossover design.

Participants in each cohort were randomized to receive treatment with TAK-071 or matching placebo using drug-in-capsule (DIC) in the morning following a minimum fast of 8 hours. In Cohort 16, participants were assigned to 1 of 2 possible treatments, TAK-071 or matching placebo. In Cohort 17, participants were assigned to 1 of 3 treatment sequences (ABC, BCA, or CAB) with treatment A being fasted state and capsule formulation, treatment B being fasted state and tablet formulation, and treatment C being fed state and tablet formulation. In Cohorts 20-22, participants were administered as a single dose of TAK-071 or placebo on Day 1, and a single dose of donepezil or placebo approximately 24 hours later on Day 2.

This multi-center trial was conducted in United States. The overall time to participate in this study was approximately 41 days. Participants made multiple visits to the clinic and were also contacted for the follow-up through the telephone.

Eligibility criteria: Inclusion Criteria:

1. Man or woman who weighs at least 50 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m\^2, inclusive, at Screening. Participants should be aged 18 to 55 years, inclusive (nonelderly at the time of informed consent and first study drug dose) for Cohorts 1 to 12, and 17 to 22; 20 to 55 years, inclusive, for Cohorts 13 to 15; and 55 to 90 years, inclusive, for participants in Cohort 16.
2. For Cohorts 13 to 15 only: First-generation Japanese, defined as having been born in Japan of Japanese parents and Japanese grandparents and living no more than 10 years outside of Japan, with no significant change in lifestyle, including diet, while living outside of Japan.
3. Cohort 16 only: Healthy elderly or participants with MCI or mild AD, who must have Mini Mental State Examination (MMSE) score of 18 to 30, inclusive or 18 to 26 inclusive, respectively, and no biomarker data to contradict this diagnosis. Participants with documented diagnosis of MCI or mild AD must be receiving ongoing donepezil therapy (10 mg) in the evening for a minimum of 21 days prior to Check-in (Day -1) or must consent to take donepezil dose titrated to at least 21 days of treatment with 10 mg QD prior to Check-in.

Exclusion Criteria:

1. Has clinically significant (Cohorts 1 to 15 and 17 to 22) or uncontrolled (Cohort 16) neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (GI), urologic, immunologic, endocrine, or psychiatric disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
2. Has a history of type 1 diabetes (Cohorts 1 to 22) or type 2 diabetes (Cohorts 1 to 15, 17 to 22) or hemoglobin A1c \>6.5% at Screening. Note: participants with controlled (hemoglobin A1c \<7.0% at Screening) type 2 diabetes in Cohort 16 may participate in the study.
3. Has a risk of suicide or suicidal ideation with intent and plan according to the investigator's clinical judgment (affirmative answer to questions 4 and 5 of the ideation section of the Columbia-Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.
4. Cohort 16 only: Any significant neurologic disease (other than suspected incipient or mild AD), such as Parkinson disease, stroke, transient ischemic attack, multi-infarct dementia, Huntington disease, head trauma with clinically significant cognitive sequelae, or chronic central nervous system infection, per investigator discretion.
5. Has current or recent (within 6 months) GI disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption \[eg, bariatric surgery or bowel resection\], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent \[more than once per week\] occurrence of heartburn).

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Day 1 up to Day 41
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose
timeFrame: Day 1 up to Day 41
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
timeFrame: Day 1 up to Day 41
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose
timeFrame: Day 1 up to Day 41
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]
timeFrame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8]
timeFrame: Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28]
timeFrame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8]
timeFrame: Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28]
timeFrame: Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]
timeFrame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8]
timeFrame: Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28]
timeFrame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8]
timeFrame: Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28]
timeFrame: Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]
timeFrame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8]
timeFrame: Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28]
timeFrame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8]
timeFrame: Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28]
timeFrame: Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]
timeFrame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose
measure: AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil
timeFrame: Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose
Secondary outcomes:
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and multiple timepoints (up to 24 hrs) post-dose for Cohorts 7 and 8 and Pre-dose on Day 1 and multiple timepoints (up to 96 hrs) post-dose for Cohort 9
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants
timeFrame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
timeFrame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
measure: Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
measure: Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
timeFrame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
measure: CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
measure: CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect
timeFrame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
measure: Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
measure: Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9
measure: Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants
timeFrame: Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose
measure: Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose
measure: Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9
measure: Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants
timeFrame: Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose
measure: Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose
measure: AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose
measure: AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8, and pre-dose on Day 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9
measure: AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
measure: Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose
measure: Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9
measure: Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
measure: CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose
measure: CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants
timeFrame: Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 multiple time points (up to 96 hours) post-dose for Cohort 9
measure: CLR: Renal Clearance for TAK-071 MRD Japanese Participants
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
measure: CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose
measure: CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071
timeFrame: Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose
measure: CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071
timeFrame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose
measure: CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071
timeFrame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
measure: Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071
timeFrame: Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose
measure: Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071
timeFrame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants
timeFrame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants
timeFrame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil
timeFrame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
measure: Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071
timeFrame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
measure: Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071
timeFrame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: