Primary Objective: To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir 100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary Objective(s): To assess the safety of multiple oral doses of BMS-…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pharmacokinetics
Secondary outcome
- Safety
Background summary
The drug to be given, BMS-790052, is a new, investigational compound that may
eventually be used for the treatment of Hepatitis C. The current standard of
care for treating Hepatitis C fails more frequently in individuals co-infected
with HIV. In addition, current therapies are unpleasant to administer and are
associated with significant side effects. The study medication is being
developed for the treatment of Hepatitis C, also in patients co-infected with
HIV, and to address some of the shortcomings of the current treatments. The
study medication inhibits a multifunctional protein that plays an important
role in the replication and functioning of the Hepatitis C virus. This new
compound is not registered as a drug, but has been given to humans before.
During this study you will also receive Ritonavir and Atazanavir. Ritonavir and
Atazanavir have been registered as drugs for the treatment of HIV/AIDS. The
combination of both drugs is used in the treatment of patients with HIV/AIDS
and is frequently used in patients co-infected with Hepatitis C
Study objective
Primary Objective:
To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir
100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.
Secondary Objective(s):
To assess the safety of multiple oral doses of BMS-790052 given alone and
together with multiple doses of atazanavir plus ritonavir.
Study design
This will be an open-label, two-treatment, single-sequence crossover,
multiple-dose, one-way interaction study in healthy subjects. Subjects will be
screened and enrolled into the study up to 21 days prior to Day 1. All subjects
will receive 2 treatments, A and B, sequentially.
Treatment A: multiple doses of BMS-790052 60 mg (2 x 30 mg tablets), orally,
QD, administered after a light breakfast on Days 1 to 4.
Treatment B: multiple doses of BMS-790052 20 mg (2 x 10 mg tablets), orally,
QD, simultaneously with atazanavir 300 mg + ritonavir 100 mg, orally, QD,
administered after a light breakfast on Days 5 to 14. Subjects will be
discharged on Day 15.
Procedures and assessments:
Screening and follow-up: clinical laboratory, full physical examination, Vital
signs (BP, HR, OBT, RR), ECG and pregnancy test (females only).; at eligibility
screening: medical history, drug screen, HBsAg, anti HCV, anti-HIV1/2, and HIV
viral load.
Observation period:
in clinic from -17 h up to 24 h after first drug administration(Day -1 to Day
15)
Blood sampling:
for pharmacokinetics of BMS-790052: pre-dose on Days 8, 10, 12 and 13, pre-dose
and 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24h after dosing on Days 4 and 14 for
pharmacokinetics of atazanavir: pre-dose and 1, 2, 4, 6, 12, 16, and 24h after
dosing on Day 14
Safety assessments:
Safety assessments: adverse events throughout the study; vital signs, ECG: pre
dose on Days 1, 5, and 10, and on Day 15; clinical laboratory: predose on Day
4 and 10, and on Day 15
Bioanalysis:
analysis of BMS 790052 samples using a validated LC-MS/MS method by the
sponsor, analysis of atazanavir samples using a validated LC-MS/MS method by
the sponsor if deemed necessary
Intervention
Active substance: BMS-790052, atazanavir, ritonavir
Study burden and risks
Procedures: pain, light bleeding, heamatoma, possibly an infection.
Chaussée de la Hulpe 185
1170 Brussel
BE
Chaussée de la Hulpe 185
1170 Brussel
BE
Listed location countries
Age
Inclusion criteria
Age: 18-49 years, inclusive
BMI: 18.0 - 32.0 kg/m2, inclusive
Women of child bearing potential should use adequate contraception (e.g., double barrier method) until at least 4 weeks after last dose of study medication
Exclusion criteria
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal disease indicated as clinically relevant by the Medical Investigator.
- Any major surgery within 4 weeks of study drug administration.
- Any gastrointestinal surgery that could impact upon the absorption of study drug.
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 90 days of study drug administration.
- Blood transfusion within 90 days of study drug administration.
- Inability to tolerate oral medication.
- Inability to swallow oral medication in the form of tablets or capsules.
- Inability to be venipunctured and/or tolerate venous access.
- Smoking more than 5 cigarettes per day.
- Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse (see Appendix 1).
- History of cardiac conduction abnormalities.
- History of nephrolithiasis.
- Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- Positive urine screen for drugs of abuse.
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV viral load, or HIV-1, -2 antibody
- History of any significant drug allergy (such as Stevens-Johnson Syndrome, anaphylaxis or hepatotoxicity).
- Pregnancy or lactation (females only).
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease)
illness.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023213-60-NL |
| CCMO | NL35264.056.11 |