Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

Launched by TOBIRA THERAPEUTICS, INC. · Apr 4, 2013

Keywords

ClinConnect Summary

Primary Objectives

* To evaluate the steady-state PK of CVC administered with and without DTG .
* To evaluate the steady-state PK of DTG administered with and without CVC .
* To evaluate the PK of a single dose of Midazolam administered with and without steady state CVC when both are administered orally.

Secondary Objectives

* To evaluate the safety and tolerability of CVC administered with and without DTG.
* To evaluate the safety and tolerability of CVC administered with and without Midazolam.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provide written informed voluntary consent
• • 2. Adult male and female healthy volunteers
• • 3. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
• • 4. Be in good general health with no clinically relevant abnormalities
• • 5. Agree to comply with study procedures and restrictions
• Exclusion Criteria:
• • 1. Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator
• • 2. History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed
• • 3. Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication
• • 4. Known or suspected hypersensitivity or allergic reaction to any of the components of CVC or DTG tablets, or midazolam syrup
• • 5. Serum ALT, AST, or bilirubin values greater than or equal to Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 1 at screening