Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K-877; Drug: CSG452

Study type: Interventional

Funder types: Industry

Identifiers

NCT04237597

K-001-001

Details and patient eligibility

About

A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 other inclusion criteria outlined in the clinical study protocol

Exclusion criteria

• Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
• Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
• Subject does not meet any other exclusion criteria outlined in the clinical study protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

K-877 & CSG452

Experimental group

Description:

K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15

Treatment:

Drug: K-877

Drug: CSG452