Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects
This study is not yet open for participant recruitment.
Verified February 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00996879
First received: October 14, 2009
Last updated: March 28, 2013
Last verified: February 2012
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Purpose
The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: Midazolam Drug: BMS-791325 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax) [ Time Frame: Within 24 hours of dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests [ Time Frame: On Days 1, 2, 4, 6, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Midazolam + BMS-791325 |
Drug: Midazolam
Syrup, Oral, 5 mg, Single dose, 2 days
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 8 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
- Women who are not of childbearing potential
Exclusion Criteria:
- Women of childbearing potential
- Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
- Gastrointestinal disease that may impact the absorption of study drug
- History of any chronic respiratory disease (asthma, COPD)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996879
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Locations
| United States, Kansas | |
| Pra International | Terminated |
| Lenexa, Kansas, United States, 66219 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00996879 History of Changes |
| Other Study ID Numbers: | AI443-006 |
| Study First Received: | October 14, 2009 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Human Volunteers |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013