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

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of CMX157 in Healthy Adult Volunteers.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Viread; Drug: CMX157

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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: Viread; One single oral dose of 300mg 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chimerix
• Investigators: Principal Investigator: Stephen Flach, MD, Covance

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 3, 2010
• First Submitted That Met QC Criteria: March 3, 2010
• First Posted (Estimate): March 4, 2010

Study Record Updates

• Last Update Posted (Estimate): July 4, 2011
• Last Update Submitted That Met QC Criteria: June 30, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy adult volunteers
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine
• Other Study ID Numbers: CMX157-101/A01