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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03702673

Enrollment

Registered

2018-10-11

Start date

2018-10-05

Completion date

2018-11-20

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGK-877 CR Tablet E

K-877 Controlled Release Tablet E

DRUGK-877 IR Tablet

K-877 Immediate Release Tablet

DRUGK-877 CR Tablet A

K-877 Controlled Release Tablet A

DRUGK-877 CR Tablet B

K-877 Controlled Release Tablet B

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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 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

Design outcomes

Primary

Measure	Time frame
Area Under the Plasma Concentration Versus Time Curve (AUC)	Up to 24 hours after single administration
Maximum Measured Plasma Concentration (Cmax)	Up to 24 hours after single administration

Secondary

Measure	Time frame
Treatment emergent adverse events summarized by treatment	Up to 16 days after administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026