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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702673
• Other study ID #: K-877-101CR
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: December 2018
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• K-877 CR Tablet A
K-877 Controlled Release Tablet A
• K-877 CR Tablet B
K-877 Controlled Release Tablet B
• K-877 CR Tablet E
K-877 Controlled Release Tablet E
• K-877 IR Tablet
K-877 Immediate Release Tablet

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC)		Up to 24 hours after single administration
Primary	Maximum Measured Plasma Concentration (Cmax)		Up to 24 hours after single administration
Secondary	Treatment emergent adverse events summarized by treatment		Up to 16 days after administration