Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||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|
- Pharmacokinetic Assessment of Cenicriviroc [ Time Frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20 ] [ Designated as safety issue: No ]PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9 & 12-19.
- Pharmacokinetic Assessment of Dolutegravir [ Time Frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20 ] [ Designated as safety issue: No ]PK profile will be calculated based on DTG exposure. Trough (predose) DTG plasma samples will be obtained prior to dosing on Days 2-9 & 12-19.
- Pharmacokinetic Assessment of Midazolam and alpha-hydroxymidazolam [ Time Frame: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 & 18 hours postdose on Day -1 and Day 9 ] [ Designated as safety issue: No ]PK profile will be calculated (Group 1 only) based on plasma midazolam & alpha-hydroxymidazolam exposure.
- Number of participants with adverse events [ Time Frame: Participants will be followed upon taking first dose of study medication until the follow-up visit, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]
Physical examinations, vital signs, ECGs, clinical laboratory tests, and AEs or serious AEs (SAEs) will be assessed at specified time points according to the Schedule of Procedures in the protocol. In addition, arterial oxygen saturation will be monitored by pulse oximetry for at least 2 hours after administration of midazolam on Days -1 and 9 in Group 1.
For both groups, a final follow-up visit will occur 14 days (±3 days) after the last dose of study medication, or at the time of early termination (if applicable) to evaluate any remaining safety issue(s).
|Study Start Date:||March 2013|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Cenicriviroc + Midazolam, and CVC + DTG
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.
Other Name: CVCDrug: Dolutegravir
Other Name: DTGDrug: Midazolam
Experimental: Dolutegravir , and DTG + CVC
Grp 2: DTG 50 mg qd alone from Days 1-10, DTG 50 mg qd + CVC 150 mg qd from Days 11-20.
Other Name: CVCDrug: Dolutegravir
Other Name: DTG
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01827540
|United States, Florida|
|SeaView Research, Inc.|
|Miami, Florida, United States, 33126|
|Principal Investigator:||Audrey Martinez, MD||SeaView Research, Inc.|