A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers

NCT01080820 | Completed Phase 1

• 1 other identifier: CMX157-101/A01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and the time that it takes to eliminate CMX157 following one oral dose when given to healthy volunteers.

Conditions

Healthy

Keywords

Healthy adult volunteers; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogram

  dosing-28 days post-dose

Secondary Outcomes (1)

• CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration.

  dosin - 28 days post-dose

Study Arms (3)

Placebo + Viread

PLACEBO COMPARATOR

Drug: Placebo; Drug: Viread

Viread

ACTIVE COMPARATOR

Drug: Viread

CMX157 + Viread

EXPERIMENTAL

Drug: CMX157; Drug: Viread

Interventions

CMX157 DRUG

One single oral dose of CMX157 will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the CMX157 dose.

CMX157 + Viread

Placebo DRUG

One single oral dose of placebo will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the placebo dose.

Placebo + Viread

Viread DRUG

One single oral dose of 300mg Viread.

CMX157 + Viread; Placebo + Viread; Viread

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Males or females of non-childbearing potential, 18 to 55 years of age. Males must be able and willing to use adequate contraceptive methods throughout the study.

You may not qualify if:

• Currently nursing females, pregnant females, or females of child-bearing potential.
• Hypersensitivity to tenofovir.
• Use of any antiviral, corticosteroid, immunosuppressive, or anticoagulant prescription drug within 4 weeks prior to enrollment. Use of any other prescription drug within 14 days prior to enrollment.
• Use of any over-the-counter medication, herbal/nutraceutical preparation, within 7 days prior to enrollment.
• Administration of any potentially nephrotoxic drug within 14 days prior to enrollment.
• Use of an investigational drug and/or treatment within 30 days prior to enrollment.
• Use of illicit drugs within 6 months prior to screening and enrollment, based on history and a urine drug screen.
• Infection with HIV, HBV or HCV.
• History of abuse of alcohol or other substance (s) within 6 months prior to enrollment.
• History or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease, cardiomyopathy, and cardiac conduction disorders.
• History of clinically significant hypotension (including orthostatic), fainting, or lightheadedness.
• History of gastrointestinal disease or impairment.
• History of renal impairment or disorder.
• History of liver disease or impairment.
• History of cancer, except basal cell carcinoma.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Covance

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine; Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephen Flach, MD

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 4, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 4, 2011

Record last verified: 2011-06

Locations

US (1)