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OpenTrials
Completed

NCT Number: NCT04237597

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development. LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

K-877

Drug

K-877 tablets

CSG452

Drug

CSG452 tablets

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: 0 to 24 hours

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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