Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

Alzheimer Disease Clinical Trial

Official title:

A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860275
• Other study ID #: CN156-019
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2009
• Last updated: January 24, 2011
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and postmenopausal female subjects 18-55 yrs old inclusive

Exclusion:

• Premenopausal women

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• BMS-708163
Capsule, Oral, 50 mg, once, Day 1
• BMS-708163 + Ketoconazole
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
• Ketoconazole
Tablet, Oral, 400 mg, daily, 16 days
• Fluconazole
Tablet, Oral, 1 day 400 mg then 3 days 200 mg
• BMS-708163 + Fluconazole
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile of BMS-708163		Within 14 days after dose	No
Secondary	Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole		During the entire study period	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form