Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.

Key facts

Study ID

NCT04742218

Run by

Kowa Research Institute, Inc.

People needed

18

Starts

2021-01-13

Expected to finish

2021-04-11

Last updated by the study team

2021-08-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject provides written informed consent before any study-specific evaluation is performed;
• Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at screening;
• Subject has a BMI of 18 to 30 kg/m2, inclusive, at screening
• Subject meets all inclusion criteria outlined in the clinical study protocol

You may not qualify if…

• Subject is a woman who is pregnant or breastfeeding;
• Subject has clinically significant abnormalities in the screening or check-in assessments;
• Subject has received an investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug
• Subject does not meet any other exclusion criteria outlined in clinical study protocol.

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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