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Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

This study is not yet open for participant recruitment.
Verified January 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01766050
First received: January 10, 2013
Last updated: February 1, 2013
Last verified: January 2013
History of Changes

January 10, 2013
February 1, 2013
January 2013
April 2013   (final data collection date for primary outcome measure)
  • Systemic exposures of Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam, measured by Maximum observed plasma concentration (Cmax), after single doses of the Inje Cocktail with and without the co administration of Belatacept [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11 ] [ Designated as safety issue: No ]
  • Systemic exposures of Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam, measured by AUC(0-T), after single doses of the Inje Cocktail with and without the co administration of Belatacept [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11 ] [ Designated as safety issue: No ]
    AUC(0-T) = Area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration
  • Systemic exposures of Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam, measured by AUC(INF), after single doses of the Inje Cocktail with and without the co administration of Belatacept [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11 ] [ Designated as safety issue: No ]
    AUC(INF) = Area under the plasma concentration-time curve from time zero extrapolated to infinite time
Same as current
Complete list of historical versions of study NCT01766050 on ClinicalTrials.gov Archive Site
  • Maximum observed plasma concentration (Cmax) of 1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine after the single dose of the Inje Cocktail [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of 1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine after the single dose of the Inje Cocktail [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] of 1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine after the single dose of the Inje Cocktail [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine after the single dose of the Inje Cocktail [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of 1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine after the single dose of the Inje Cocktail [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of the Inje cocktail components (Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of the Inje cocktail components (Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT/F) of the Inje cocktail components (Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of Paraxanthine AUC(0-T) to Caffeine AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of Paraxanthine AUC(INF) to Caffeine AUC(INF), corrected for molecular weight [MR_AUC(INF)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of Paraxanthine (Cmax) to Caffeine (Cmax), corrected for molecular weight (MR_Cmax) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of E-3174 AUC(0-T) to Losartan AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of E-3174 AUC(INF) to Losartan AUC(INF), corrected for molecular weight [MR_AUC(INF)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of E-3174 (Cmax) to Losartan (Cmax), corrected for molecular weight (MR_Cmax) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of Hydroxyomeprazole AUC(0-T) to Omeprazole AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of Hydroxyomeprazole AUC(INF) to Omeprazole AUC(INF), corrected for molecular weight [MR_AUC(INF)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of Hydroxyomeprazole (Cmax) to Omeprazole (Cmax), corrected for molecular weight (MR_Cmax) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of 5-Dextrorphan AUC(0-T) to Dextromethorphan AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of 5-Dextrorphan AUC(INF) to Dextromethorphan AUC(INF), corrected for molecular weight [MR_AUC(INF)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of 5-Dextrorphan (Cmax) to Dextromethorphan (Cmax), corrected for molecular weight (MR_Cmax) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of 1'-Hydroxy-Midazolam AUC(0-T) to Midazolam AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of 1'-Hydroxy-Midazolam AUC(INF) to Midazolam AUC(INF), corrected for molecular weight [MR_AUC(INF)] [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Ratio of 1'-Hydroxy-Midazolam (Cmax) to Midazolam (Cmax), corrected for molecular weight (MR_Cmax) [ Time Frame: 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11 ] [ Designated as safety issue: No ]
  • Safety assessed by incidence of Adverse events (AEs), serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations [ Time Frame: Up to study discharge (Day 46±2) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers
An Open-label, Single-sequence Study of the Effect of Belatacept on the Pharmacokinetics of Caffeine, Losartan, Omeprazole, Dextromethorphan, and Midazolam Administered as "Inje Cocktail" in Healthy Subjects

The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam
Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Transplant Rejection
  • Drug: Caffeine
  • Drug: Losartan
  • Drug: Omeprazole
  • Drug: Dextromethorphan
  • Drug: Midazolam
  • Biological: Belatacept
    Other Names:
    • Nulojix
    • BMS-224818
Experimental: Arm: Inje Cocktail + Belatacept

Inje Cocktail consisting of (200 mg Caffeine, 50 mg losartan tablet, 40 mg Omeprazole capsule, 30 mg Dextromethorphan capsule and 5 mg Midazolam oral syrup) administered on Days 1, 4, 7 and 11

Belatacept 10 mg/kg Intravenous (IV) solution, administered on Day 4

Interventions:
  • Drug: Caffeine
  • Drug: Losartan
  • Drug: Omeprazole
  • Drug: Dextromethorphan
  • Drug: Midazolam
  • Biological: Belatacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
22
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI 18 to 30 kg/m2
  • Men and women ages 18 to 45

Exclusion Criteria:

  • Active tuberculosis
  • Any recent infection requiring antibiotic treatment within 4 weeks of dosing
  • Positive urine screen for drugs of abuse
Both
18 Years to 45 Years
Yes
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.
Not Provided
 
NCT01766050
IM103-151
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP