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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01080820
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : July 4, 2011
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CMX157 Drug: Placebo Drug: Viread Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 [ Time Frame: dosing-28 days post-dose ]

Secondary Outcome Measures :
  1. CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration. [ Time Frame: dosin - 28 days post-dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01080820

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United States, Wisconsin
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
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Principal Investigator: Stephen Flach, MD Covance
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Responsible Party: Margaret Anderson, Clinical Development Manager, Chimerix, Inc Identifier: NCT01080820    
Other Study ID Numbers: CMX157-101/A01
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011
Keywords provided by Chimerix:
Healthy adult volunteers
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents