A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 (Prodrug) From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects
Status: | Not yet recruiting |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 8/10/2016 |
Start Date: | August 2016 |
End Date: | September 2016 |
Contact: | John R Kamin, BS |
Email: | john.kamin@covance.com |
Phone: | 608-210-7536 |
Relative Bioavailability Study of BMS-626529 Administered as Prodrug BMS-663068 From 150-mg Low-dose Extended-release Tablets Compared to 600-mg Reference Extended-release Tablet in Healthy Subjects
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529
administered as BMS-663068 (Prodrug).
administered as BMS-663068 (Prodrug).
Inclusion Criteria:
1. Signed Informed Consent
2. Target Population: Healthy subjects as determined by no clinically significant
deviation from normal in medical and surgical history, physical examination, vital
sign measurements, 12-lead ECG measurements, , and clinical laboratory test results.
Body mass index (BMI) of 18.0 to 32.0 kg/m².
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has
discontinued the study as a pre-treatment failure (i.e., subject has not been
randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
4. Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
5. Reproductive Status: Women of childbearing potential (WOCBP) must have a negative
serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of human chorionic
gonadotropin) within 24 hours prior to the start of study drug. Women must not be
breastfeeding. Women of childbearing potential must agree to follow instructions for
method(s) of contraception (Appendix 1) for the duration of treatment with study drug
plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle)
for a total of 33 days post-treatment completion. Males who are sexually active with
WOCBP must agree to follow instructions for method(s) of contraception for the
duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In
addition, male subjects must be willing to refrain from sperm donation during this
time. Azoospermic males are exempt from contraceptive requirements. Women of
childbearing potential who are continuously not heterosexually active are also exempt
from contraceptive requirements, and still undergo pregnancy testing as described in
this section.
Exclusion Criteria:
1. Medical History and Concurrent Diseases: History of any chronic or acute illness,
gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of
dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of
dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability
to tolerate oral medication, or inability to be venipunctured. Any other sound
medical, psychiatric and/or social reason as determined by the investigator.
2. Physical and Laboratory Test Findings: Evidence of organ dysfunction or any
clinically significant deviation from normal in physical examination, vital signs
measurements, ECGs, or clinical laboratory determinations beyond what is consistent
with the target population.
3. Exposure to any investigational drug or placebo within 4 weeks of study drug
administration.
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