Clinical trial NCT04831502: Bioavailability and Food Effect Study of Two Formulations of TAK-906
Official title: A Phase 1, Open Label, Randomized, Single-Dose, Replicate Crossover Study to Determine the Bioavailability of the Tablet Formulation Relative to the Capsule Formulation of TAK-906 and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting.

This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.

Detailed description: The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test \[Treatment B\]) relative to single oral dose of 50 mg capsule (reference \[Treatment A\]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B).

The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences.

This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting and urine cotinine test.
2. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 kilogram per square meter (kg/m\^2) at the screening.
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs) performed at the screening visit and before administration of the initial dose of trial drug, as deemed by the investigator or designee.

Exclusion Criteria:

1. Presence of infectious diseases (example, Coronavirus disease-19 \[COVID-19\] and flu) at the time of screening or check-in.
2. Any history of major surgery that may affect absorption, metabolism or excretion of study drug (example, intestinal resections, hepatectomy, nephrectomy, cholecystectomy), and/or digestive organ resection (except appendectomy).
3. History of any illness that, in the opinion of the investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
4. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
5. Positive urine drug or alcohol results at screening or check-in.
6. Positive urine cotinine at screening.
7. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
8. QT interval corrected for heart rate using Frederica's equation (QTcF) is greater than (\>) 450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
9. Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening.
10. Unable to refrain from or anticipates the use of:

    o Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 grams \[g\] per 24 hours) may be administered at the discretion of the investigator or designee; sponsor must be consulted prior to administering acetaminophen to a participants.
11. Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within 30 days prior to the first dosing and throughout the study.
12. Is lactose intolerant or unable/unwilling to eat the high-fat, high-calorie breakfast.
13. Donation of blood or significant blood loss within 56 days prior to the first dosing.
14. Plasma donation within 7 days prior to the first dosing.
15. Participation in another clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dosing. The 30-day window or 5 half lives (whichever is longer) will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.

Primary outcomes:
measure: Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Secondary outcomes:
measure: Number of Participants Reporting one or More Adverse Events (AEs)
timeFrame: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
measure: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
timeFrame: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
measure: Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: AUC%extrap: Percent of AUCinf Extrapolated After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Tmax: Time to Reach Maximum Plasma Concentration After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Tlag: Lag Time to First Quantifiable Concentration After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Kel: Apparent Terminal First Order Elimination Rate Constant After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: CL/F: Apparent Plasma Clearance After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
measure: t½: Terminal Half-life After Single Dose of TAK-906
timeFrame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: