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
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT03482453
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 69
- Starts
- 2018-03-28
- Expected to finish
- 2019-01-18
- Last updated by the study team
- 2020-01-29
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- PRA Health Sciences — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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