Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tobira Therapeutics, Inc.
With
ViiV Healthcare
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.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
