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

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04237597
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: K-877; Drug: CSG452	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
• Actual Study Start Date: Dec 17, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Mar 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: K-877 & CSG452 K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15	Drug: K-877; K-877 tablets; Drug: CSG452; CSG452 tablets

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration versus time curve (AUC) [0 to 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development. LP	Austin	Texas	United States	78744

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT04237597
• Other Study ID Numbers: K-001-001
• First Posted: Jan 23, 2020
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Study Results

No Results Posted as of Sep 22, 2020