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

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01827540
First received: March 25, 2013
Last updated: April 8, 2014
Last verified: April 2014

March 25, 2013
April 8, 2014
March 2013
May 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01827540 on ClinicalTrials.gov Archive Site
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).

Same as current
Not Provided
Not Provided
 
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
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

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
HIV-infection/AIDS
  • Drug: Cenicriviroc
    Other Name: CVC
  • Drug: Dolutegravir
    Other Name: DTG
  • Drug: Midazolam
    Other Names:
    • Dormicum
    • Hypnovel
    • Versed
  • 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.
    Interventions:
    • Drug: Cenicriviroc
    • Drug: Dolutegravir
    • Drug: 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.
    Interventions:
    • Drug: Cenicriviroc
    • Drug: Dolutegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01827540
TBR 652-1-110
No
Tobira Therapeutics, Inc.
Tobira Therapeutics, Inc.
ViiV Healthcare
Principal Investigator: Audrey Martinez, MD SeaView Research, Inc.
Tobira Therapeutics, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP