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Completed

NCT Number: NCT01039194

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International - Baltimore Epcu

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galantamine

Drug

Capsule, Oral, 8 mg (ER), once daily, Days 1-7

Other names: Razadyne ER ™

BMS-708163

Drug

Capsule, Oral, 125 mg, once daily, Days 15-24

Primary outcomes

  1. 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)

    Time frame: Study Days 14 & 24

Secondary outcomes

  1. Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)

    Time frame: Study Days 7, 14, 18, 25 and study discharge

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 24, 2009
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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