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

Tobira Therapeutics

Status and phase: Completed; Phase 1

Conditions: HIV-infection/AIDS

Treatments: Drug: Midazolam; Drug: Cenicriviroc; Drug: Dolutegravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01827540

TBR 652-1-110

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Cenicriviroc + Midazolam, and CVC + DTG

Experimental group

Description:

Grp 1: CVC 150mg qd alone from Days 1-10; CVC 150mg qd + DTG 50mg qd from Days 11-20. A single dose of midazolam 5mg administered alone on Day -1 \& w/ CVC 150mg on Day 9.

Treatment:

Drug: Dolutegravir

Drug: Cenicriviroc

Drug: Midazolam

Dolutegravir , and DTG + CVC

Experimental group

Description:

Grp 2: DTG 50 mg qd alone from Days 1-10, DTG 50 mg qd + CVC 150 mg qd from Days 11-20.

Treatment:

Drug: Dolutegravir

Drug: Cenicriviroc