Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment A K-877 CR Tablet A |
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
|
| Experimental: Treatment B K-877 CR Tablet B |
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
|
| Experimental: Treatment C K-877 CR Tablet E |
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
|
| Experimental: Treatment D K-877 IR Tablet |
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Treatment emergent adverse events summarized by treatment [Up to 16 days after administration]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PPD Development, LP | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Kowa Research Institute, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K-877-101CR