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CompletedNCT01080820Updated Jul 4, 2011

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

A Phase 1 interventional study of CMX157 and Placebo in Healthy, sponsored by Chimerix. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-04.

Sponsored by Chimerix · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy adult volunteers
  • Pharmacokinetics
03

In context

Lead sponsor

Chimerix is the lead sponsor of 33 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (estimated)

Study arms

  • Placebo comparator
    Placebo + Viread

    Drug: Placebo · Drug: Viread

  • Active comparator
    Viread

    Drug: Viread

  • Experimental
    CMX157 + Viread

    Drug: CMX157 · Drug: Viread

Interventions

  • DrugCMX157

    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.

  • DrugPlacebo

    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.

  • DrugViread

    One single oral dose of 300mg Viread.

06

What researchers measure

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

    Time frame: dosing-28 days post-dose

Secondary outcomes

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

    Time frame: dosin - 28 days post-dose

07

Study locations

1 site
  • Covance
    Madison, Wisconsin 53704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01080820
Lead sponsor
Chimerix
First posted
Mar 4, 2010
Start date
Jun 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jul 4, 2011

Study contacts

Stephen Flach, MD
principal investigator · Covance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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