Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Jazz Pharmaceuticals24 enrolled

Overview

The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CMX001DRUG

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males and non-childbearing females 18-55 years old Exclusion Criteria: * Use of an investigational drug and/or treatment within 30 days prior to enrollment. * Positive HIV, Hepatitis B or Hepatitis C test result * Tobacco user * History of GI disease or disorder * History of positive fecal occult blood test (FOBT) * Body Mass Index (BMI) \> 30 or \< 18, or body weight \< 50 kg * Prior abdominal or pelvic surgery

Locations (1)

AAI Pharma

Rtp, North Carolina, United States

Outcomes

Primary Outcomes

AUC and Cmax of CMX001 and cidofovir

Time frame: Each of 3 doses

Secondary Outcomes

Clinical and laboratory endpoints and adverse events

Time frame: Throughout the study

Data from ClinicalTrials.gov

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