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NCT05722262
Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
Conditions: Healthy
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 30
Sponsor: Kowa Research Institute, Inc.
Summary
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.
Eligibility Criteria
Inclusion Criteria:Participant provides written informed consent before any study-specific evaluation is performed.Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.Participant meet all other inclusion criteria outlined in the clinical study protocol.Exclusion Criteria:Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.Participant meets any other exclusion criteria outlined in the clinical study protocol.
Source: ClinicalTrials.gov (NCT05722262). StuddyBuddy aggregates publicly available trial information.