Status:
COMPLETED
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
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
The drug being tested in this study is called TAK-788. The study will assess the safety and tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of TAK-788 and will...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2019
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03482453
Start Date
March 28 2018
End Date
January 18 2019
Last Update
January 29 2020
Active Locations (1)
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1
PRA Health Sciences
Salt Lake City, Utah, United States, 84124