Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

Tobira Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omeprazole; Drug: Famotidine; Drug: Cenicriviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT02684799

652-123

Details and patient eligibility

About

This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC

Enrollment: 48 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.
• Have a positive Helicobacter pylori urea breath test.
• Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, OME or FAM 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Part 1 Group 1 (Cenicriviroc)

Experimental group

Description:

Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13.

Treatment:

Drug: Cenicriviroc

Part 1 Group 1 (Omeprazole)

Active Comparator group

Description:

Part 1 Group 1 (12 subjects) will receive Omeprazole 20 mg from Days 2-7, and Omeprazole 40 mg from Days 8-13.

Treatment:

Drug: Omeprazole

Part 1 Group 2 (Cenicriviroc)

Experimental group

Description:

Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13.

Treatment:

Drug: Cenicriviroc

Part 1 Group 2 (Famotidine)

Active Comparator group

Description:

Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13.

Treatment:

Drug: Famotidine

Part 2 (Cenicriviroc)

Experimental group

Description:

Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20.

Treatment:

Drug: Cenicriviroc

Part 2 (Omeprazole)

Active Comparator group

Description:

Part 2 (24 subjects) will receive Omeprazole from Days 11-20.

Treatment:

Drug: Omeprazole