Phase 1
Completed N=40
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT03482453 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 2; 2; 3; 4 Participants
Summary
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
2; 2; 3; 4; 3; 5 | — |
| PRIMARY Part 1: Number of Participants With One or More Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788 |
27.52; 31.24; 39.51; 41.00 | — |
| PRIMARY Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788 |
44.77; 41.71 | — |
| PRIMARY Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 |
6.0; 4.0; 6.0; 6.0 | — |
| PRIMARY Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 |
6.0; 5.0 | — |
| PRIMARY Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 |
526.3; 518.3; 700.6; 733.6 | — |
| PRIMARY Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 |
706.1; 677.9 | — |
| PRIMARY Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 |
533.8; 525.8; 706.3; 743.0 | — |
| PRIMARY Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 |
738.8; 709.5 | — |
| PRIMARY Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 |
17.17; 17.60; 20.72; 20.62 | — |
| PRIMARY Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 |
16.38; 16.38 | — |
| SECONDARY Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914 |
3.22; 7.85; 14.66; 25.81; 52.21; 1.546 | — |
| SECONDARY Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914 |
6.0; 5.0; 4.0; 6.0; 6.0; 6.0 | — |
| SECONDARY Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914 |
59.4; 155.2; 250.4; 448.3; 1007.8; 32.7 | — |
| SECONDARY Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914 |
63.6; 160.4; 256.9; 456.1; 1017.3; 37.4 | — |
| SECONDARY Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914 |
18.07; 15.95; 14.25; 18.30; 19.85; 23.96 | — |
| SECONDARY Parts 2 and 3: Number of Participants Reporting One or More TEAEs |
3; 3; 7; 5; 4; 4 | — |
| SECONDARY Parts 2 and 3: Number of Participants With One or More SAEs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.
- Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
- Normal organ function including hepatic, renal, and bone marrow function.
Exclusion Criteria
- Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.
- Pulmonary infection ongoing or within 30 days of informed consent.
- Inability to undergo venipuncture and/or tolerate venous access.
- Inability to tolerate multiple blood sampling.
- Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.
Data sourced from ClinicalTrials.gov (NCT03482453). 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.