Status:
COMPLETED
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
Lead Sponsor:
Tobira Therapeutics, Inc.
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-infection/AIDS
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01827540
Start Date
March 1 2013
End Date
May 1 2013
Last Update
April 9 2014
Active Locations (1)
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1
SeaView Research, Inc.
Miami, Florida, United States, 33126