Phase 1
Completed N=36
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
Dose Finding Study
Source: ClinicalTrials.gov NCT02706834 ↗
Enrolled (actual)
36
Serious AEs
0.8%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE) — 30.0; 55.6; 37.5; 14.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE) |
30.0; 55.6; 37.5; 14.3; 0; 12.5 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) |
0; 11.1; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose |
0; 0; 0; 0; 0; 12.5 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose |
20.0; 33.3; 25.0; 28.6; 0; 25.0 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828) |
5.96; 38.6; 247; 1150; 4820; 8900 | — |
| SECONDARY Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828) |
1.00; 1.00; 1.00; 1.00; 1.00; 1.00 | — |
| SECONDARY t1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828) |
5.38; 4.94; 6.53; 7.51; 7.53; 7.04 | — |
| SECONDARY 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) |
214; 1150; 5930; 23100; 45400; 38000 | — |
Eligibility Criteria
Inclusion Criteria: -
- Is a healthy male and female (non-child bearing potential) participants.
- 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).
- 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: -
- 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.
Data sourced from ClinicalTrials.gov (NCT02706834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.