Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Chimerix
ClinicalTrials.gov Identifier:
NCT01080820
First received: March 3, 2010
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: CMX157
Drug: Placebo
Drug: Viread
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of CMX157 in Healthy Adult Volunteers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chimerix:

Primary Outcome Measures:
  • 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 [ Time Frame: dosing-28 days post-dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration. [ Time Frame: dosin - 28 days post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Viread Drug: Placebo
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.
Drug: Viread
One single oral dose of 300mg Viread.
Active Comparator: Viread Drug: Viread
One single oral dose of 300mg Viread.
Experimental: CMX157 + Viread Drug: CMX157
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.
Drug: Viread
One single oral dose of 300mg Viread.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. 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.

Exclusion Criteria:

  1. Currently nursing females, pregnant females, or females of child-bearing potential.
  2. Hypersensitivity to tenofovir.
  3. 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.
  4. Use of any over-the-counter medication, herbal/nutraceutical preparation, within 7 days prior to enrollment.
  5. Administration of any potentially nephrotoxic drug within 14 days prior to enrollment.
  6. Use of an investigational drug and/or treatment within 30 days prior to enrollment.
  7. Use of illicit drugs within 6 months prior to screening and enrollment, based on history and a urine drug screen.
  8. Infection with HIV, HBV or HCV.
  9. History of abuse of alcohol or other substance (s) within 6 months prior to enrollment.
  10. History or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease, cardiomyopathy, and cardiac conduction disorders.
  11. History of clinically significant hypotension (including orthostatic), fainting, or lightheadedness.
  12. History of gastrointestinal disease or impairment.
  13. History of renal impairment or disorder.
  14. History of liver disease or impairment.
  15. History of cancer, except basal cell carcinoma.
  16. History of pathologic bone fractures; history or risk of osteopenia
  17. History of diabetes, metabolic disease, or autoimmune disease; history of immunodeficiency in healthy volunteers.
  18. Acute illness or fever 38 C within 1 week prior to enrollment.
  19. Supine blood pressure - systolic outside the range of 90-140 mmHg, or diastolic outside the range of 50-90 mmHg.
  20. Resting heart rate > 100 or < 45 beats per minute.
  21. Body Mass Index (BMI) >31 or <18, or body weight <50 kg for men and < 45 kg for women.
  22. Whole blood donation within 56 days or plasma donation within 30 days prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080820

Locations
United States, Wisconsin
Covance
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Chimerix
Investigators
Principal Investigator: Stephen Flach, MD Covance
  More Information

No publications provided

Responsible Party: Margaret Anderson, Clinical Development Manager, Chimerix, Inc
ClinicalTrials.gov Identifier: NCT01080820     History of Changes
Other Study ID Numbers: CMX157-101/A01
Study First Received: March 3, 2010
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Chimerix:
Healthy adult volunteers
Pharmacokinetics

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 17, 2013