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

Completed · Phase 1

Conditions studied: HIV-infection/AIDS

In brief

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.

Key facts

Study ID

NCT01827540

Run by

Tobira Therapeutics, Inc.

People needed

20

Starts

2013-03-01

Expected to finish

2013-05-01

Last updated by the study team

2014-04-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide written informed voluntary consent
• Adult male and female healthy volunteers
• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
• Be in good general health with no clinically relevant abnormalities
• Agree to comply with study procedures and restrictions

You may not qualify if…

• Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator
• History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed
• Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication
• Known or suspected hypersensitivity or allergic reaction to any of the components of CVC or DTG tablets, or midazolam syrup
• Serum ALT, AST, or bilirubin values greater than or equal to Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 1 at screening

Where it is running

• SeaView Research, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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