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

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet A; Drug: K-877 IR Tablet; Drug: K-877 CR Tablet E

Study type: Interventional

Funder types: Industry

Identifiers

NCT03702673

K-877-101CR

Details and patient eligibility

About

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.

Enrollment: 12 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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 4 patient groups

Treatment A

Experimental group

Description:

K-877 CR Tablet A

Treatment:

Drug: K-877 CR Tablet B

Drug: K-877 IR Tablet

Drug: K-877 CR Tablet A

Drug: K-877 CR Tablet E

Treatment B

Experimental group

Description:

K-877 CR Tablet B

Treatment:

Drug: K-877 CR Tablet B

Drug: K-877 IR Tablet

Drug: K-877 CR Tablet A

Drug: K-877 CR Tablet E

Treatment C

Experimental group

Description:

K-877 CR Tablet E

Treatment:

Drug: K-877 CR Tablet B

Drug: K-877 IR Tablet

Drug: K-877 CR Tablet A

Drug: K-877 CR Tablet E

Treatment D

Experimental group

Description:

K-877 IR Tablet

Treatment:

Drug: K-877 CR Tablet B

Drug: K-877 IR Tablet

Drug: K-877 CR Tablet A

Drug: K-877 CR Tablet E