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

A Phase I, Multiple-Dose, Open-Label, Crossover Study in Healthy Subjects to Assess the Effect of Dolutegravir (DTG) on the Pharmacokinetics (PK) of Cenicriviroc (CVC) and the Effect of CVC on the PK of DTG and on a Single Dose of Midazolam

To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.

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.

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