Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)

Alzheimer Disease Clinical Trial

Official title:

A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039194
• Other study ID #: CN156-009
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2009
• Last updated: January 24, 2011
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: February 2010
• 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 find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy men and postmenopausal women

Exclusion Criteria:

• Gastrointestinal disorders

• Bleeding disorders

• Peptic ulcer disease

• Cholecystectomy

• Seizure disorder

• Asthma

• Chronic obstructive pulmonary disease

• Urinary tract obstruction

• Cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes

• Inability to tolerate oral medication

• Inability to be venipunctured and/or tolerate venous access

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• galantamine
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
• galantamine
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
• BMS-708163
Capsule, Oral, 125 mg, once daily, Days 15-24

Locations

Country	Name	City	State
United States	Parexel International - Baltimore Epcu	Baltimore	Maryland

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	Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)		Study Days 14 & 24	No
Secondary	Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)		Study Days 7, 14, 18, 25 and study discharge	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