Skip to main content
OpenTrials
Completed

NCT Number: NCT03702673

Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.

A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.

Completed

Looking for future studies?

Notify Me

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 aged 18 to 45 years, inclusive.
  • Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
  • Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion criteria

  • Subject has clinically relevant abnormalities in the screening or check-in assessments.
  • Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
  • Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
  • Subject does not meet any exclusion criteria outlined in the clinical study protocol.

Treatment and study plan

K-877 CR Tablet A

Drug

K-877 Controlled Release Tablet A

K-877 CR Tablet B

Drug

K-877 Controlled Release Tablet B

K-877 CR Tablet E

Drug

K-877 Controlled Release Tablet E

K-877 IR Tablet

Drug

K-877 Immediate Release Tablet

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC)

    Time frame: Up to 24 hours after single administration

  2. Maximum Measured Plasma Concentration (Cmax)

    Time frame: Up to 24 hours after single administration

Secondary outcomes

  1. Treatment emergent adverse events summarized by treatment

    Time frame: Up to 16 days after administration

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study title

Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2018
Registry last updated
Dec 19, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.