Clinical trial NCT02706834: Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
Official title: A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Non-Japanese and Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dose Finding Study
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 36
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 purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.

Detailed description: The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.

The study enrolled 36 healthy participants. An interleaving crossover design with placebo substitution was used for Cohorts 1 and 2, and a crossover design was used in Cohort 3. Each cohort consisted of 12 participants, and participants were randomized to treatment sequence to receive TAK-828 or placebo after undergoing a fasting stage of at least 8 hours through intervention periods 1-4 for Cohorts 1 and 2 and through intervention periods 1 - 3 for Cohort 3. The assigned treatment sequence will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). An additional interventional period 5 (fed state) is planned to be conducted in either cohort 1 or 2, based on the dose of TAK-828 that will be chosen to be studied under fed conditions. Cohorts 1 and 2 were conducted in non-Japanese participants and Cohort 3 in Japanese participants.

This multi-center trial was conducted in the United States. Participants remained confined to the study site from check-in (Day -1) through Day 4 of each intervention period and returned 7 to 10 days after last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria: -

1. Is a healthy male and female (non-child bearing potential) participants.
2. Cohorts 1 and 2: non-Japanese participants aged 18 to 55 years, inclusive, with body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\^ 2), inclusive, and body weight greater than or equal (\>=) 50 kilograms (kg).
3. Cohort 3: Japanese participants (born to Japanese parents and grandparents) aged 20 to 55 years, inclusive, with BMI of 18.5 to 25 kg/m\^ 2, inclusive, and body weight \>= 45 kg.

Exclusion Criteria: -

1. Has used prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to Check-in (Day -1). Herbal supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less than equal to (\<=) 1 gram per day (g/day). Limited use of nonprescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)
timeFrame: Day 1 up to 30 days after last dose of study drug (up to 85 days)
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
timeFrame: Day 1 up to 30 days after last dose of study drug (up to 85 days)
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
timeFrame: Day 1 up to 7 days after last dose of study drug (up to 52 days)
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
timeFrame: Day 1 up to 7 days after last dose of study drug (up to 52 days)
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose
timeFrame: Day 1 up to 7 days after last dose of study drug (up to 52 days)
Secondary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828)
timeFrame: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose
measure: Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828)
timeFrame: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose
measure: t1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828)
timeFrame: Day 1 pre-dose and at multiple timepoints (up to 72 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-828F (Free Base of TAK-828)
timeFrame: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: