The purpose of the study is to investigate the effect of multiple oral doses of Tenofovir on how quickly and to what extent BMS-790052 is absorbed and eliminated from the body and the effect of multiple oral doses of BMS-790052 on how quickly and to…
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. BMS-790052 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. BMS-790052 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 Tenofovir. Tenofovir is registered as a
drug given to patients with HIV/AIDS. This drug is used in the treatment of
patients with HIV/AIDS and is frequently used in patients co-infected with
Hepatitis C
Study objective
The purpose of the study is to investigate the effect of multiple oral doses of
Tenofovir on how quickly and to what extent BMS-790052 is absorbed and
eliminated from the body and the effect of multiple oral doses of BMS-790052 on
how quickly and to what extent Tenofovir is absorbed and eliminated from the
body. The study will also investigate how safe the combination of Tenofovir and
the study medication is and how well this combination is tolerated.
Study design
an open-label, three-treatment, randomized-sequence, multiple-dose, two-way
interaction study in twentyone healthy male and/or healthy female subjects each
receiving each of the three treatments with no washout between treatments; in
Treatment A subjects will receive an oral dose of BMS-790052 once daily for
seven days in the fasted state; in Treatment B subjects will receive an oral
dose of tenofovir once daily for seven days in the fasted state; in Treatment C
subjects will receive an oral dose of BMS-790052 in combination with an oral
dose of tenofovir once daily for seven days in the fasted state.
Procedures and assessments:
Screening and follow-up
clinical laboratory, physical examination, weight, vital signs (including OBT
and RR), 12-lead ECG; at eligibility screening: medical history, drug screen,
HBsAg, anti HCV, anti-HIV 1/2, HIV viral load (PCR) and pregnancy test (females
only); physical examination, weight, clinical laboratory, 12-lead ECG, drug
screen and pregnancy test (females only) to be repeated upon admission.
Observation period
one period in clinic from -17 h before drug administration on Day 1 up to 24 h
after last drug administration on Day 21 (Day 22)
Blood sampling
for pharmacokinetics of BMS-790052 in plasma: pre-dose and 0.5, 1, 1.5, 2, 4,
6, 8, 12, 16 and 24 h post-dose on Day 7 (Treatments A and C) for
pharmacokinetics of tenofovir in plasma: pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8,
12, 16 and 24 h post-dose on Day 7 (Treatments B and C)
Safety assessments
adverse events throughout the study; vital signs: once on Day 1, pre-dose on
Days 8 and 15 and once at discharge on Day 22; clinical laboratory: pre-dose on
Days 8 and 15 and once at discharge on Day 22
Bioanalysis
analysis of plasma BMS 790052 and tenofovir samples using validated LC-MS/MS
methods by Sponsor
Intervention
Active substance: BMS-790052, tenofovir
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 12 weeks after last dose of study medication
Exclusion criteria
- Any significant acute or chronic medical illness (especially renal disease).
- 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.
- History of renal disease including but not limited to acute renal failure and Fanconi syndrome.
- History of pathologic fracture or other significant risk factors for osteoporosis or bone loss.
- Recent (within 6 months of study drug administration) drug or alcohol abuse
- 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 (HBsAg), HIV viral load or HIV-1, -2 antibody
- Serum creatinine > upper limit of normal (ULN).
- History of any significant drug allergy (such as anaphylaxis, hepatotoxicity or rash).
- 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 | EUCTR2010-023214-31-NL |
| CCMO | NL35267.056.11 |