NCT02342067

Brief Summary

A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK of PGZ administered with and without CVC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

January 12, 2015

Last Update Submit

May 11, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic Assessment of CVC, as measured by Cmax, Cmin and AUC

    PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9, 22-29, and 32-39.

    Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40

  • Pharmacokinetic Assessment of PGZ, as measured by Cmax, Cmin and AUC

    PK profile will be calculated based on PGZ exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9, 22-29, and 32-39.

    Predose (0 hours), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 10, 30 and 40

Secondary Outcomes (5)

  • Evaluation of Adverse Events

    40 days

  • Changes from Baseline in Clinical Laboratory Tests

    40 days

  • Changes from Baseline in 12-lead ECGs

    40 days

  • Changes from Baseline in Vital Signs

    40 days

  • Changes from Baseline in Physical Examinations

    40 days

Study Arms (2)

Group 1 (Cenicriviroc, PGZ, CVC+PGZ)

EXPERIMENTAL

Treatment A: CVC 150 mg QD for 10 days followed by 10-day washout Treatment B: PGZ 45 mg QD for 10 days Treatment C: co-administration of PGZ 45 mg QD + CVC 150 mg QD for 10 days

Drug: Cenicriviroc

Group 2 (Pioglitazone, CVC, CVC+PGZ)

EXPERIMENTAL

Treatment B: PGZ 45 mg QD for 10 days followed by 10-day washout Treatment A: CVC 150 mg QD for 10 days Treatment C: co-administration of CVC 150 mg QD + PGZ 45 mg QD for 10 days

Drug: Pioglitazone

Interventions

CenicrivirocDRUG

CVC 150 mg QD on Days 1-10, washout on Days 11-20, PGZ 45 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40

Also known as: CVC 150 mg
Group 1 (Cenicriviroc, PGZ, CVC+PGZ)
PioglitazoneDRUG

PGZ 45 mg QD on Days 1-10, washout on Days 11-20, CVC 150 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40

Also known as: PGZ 45 mg
Group 2 (Pioglitazone, CVC, CVC+PGZ)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provide written informed consent
  • BMI ≥ 18 and ≤ 35 kg/m2
  • No clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations, and 12-lead ECG
  • Agree to comply with the study procedures and restrictions

You may not qualify if:

  • Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant conditions as determined by the investigator
  • History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy
  • Serum ALT, AST or bilirubin ≥ grade 1 (ALT and AST \> ULN - 3.0 x ULN; bilirubin \> ULN - 1.5 x ULN) at screening
  • Positive for HIV, HBV or HCV infection
  • Use of any prescription drugs or prohibited medications within 30 days from the first dose of the study medication
  • Use of alcohol-containing or caffeine-containing foods or beverages within 72 hours prior to the first dose of study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

MeSH Terms

Interventions

cenicrivirocPioglitazone

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

US(1)