Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

Tobira Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Simvastatin; Drug: Atorvastatin; Drug: Caffeine; Drug: Rosuvastatin; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02685462

652-124

Details and patient eligibility

About

This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine and Digoxin

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be informed of the nature of the study and have provided written informed voluntary consent.
• Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
• Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
• Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.

Exclusion criteria

• Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
• 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.
• History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
• History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
• Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine tablets.
• History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
• If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Group 1 (Rosuvastatin)

Active Comparator group

Description:

Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13.

Treatment:

Drug: Rosuvastatin

Group 1 (Digoxin)

Active Comparator group

Description:

Group 1 (12 subjects) will receive Digoxin on Days 1 and 13.

Treatment:

Drug: Digoxin

Group 1 (Caffeine)

Active Comparator group

Description:

Group 1 (12 subjects) will receive Caffeine on Days 1 and 13.

Treatment:

Drug: Caffeine

Group 2 (Atorvastatin)

Active Comparator group

Description:

Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13.

Treatment:

Drug: Atorvastatin

Cenicriviroc

Experimental group

Description:

Subjects in Group 1 and Group 2 will receive Cenicriviroc on Days 3-12. Subjects in Group 3 will receive Cenicriviroc on Days 2-12.

Treatment:

Drug: Digoxin

Drug: Caffeine

Drug: Rosuvastatin

Drug: Atorvastatin

Drug: Simvastatin

Group 3 (Simvastatin)

Active Comparator group

Description:

Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12.

Treatment:

Drug: Simvastatin