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Trial record 45 of 70 for:    Famotidine

A Study to Determine the Drug Level Profile of Different Formulations BMS-986165 Tablets

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ClinicalTrials.gov Identifier: NCT04065932
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets

Condition or disease Intervention/treatment Phase
Lupus Drug: BMS-986165-01 Drug: BMS-986165 Tablet Drug: Famotidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered by Extended Release Solid Drug Dispersion Tablet Prototypes Using RapidFACT Technology Relative to the Immediate Release Solid Drug Dispersion Tablet in Healthy Subjects
Estimated Study Start Date : August 23, 2019
Estimated Primary Completion Date : December 7, 2019
Estimated Study Completion Date : December 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Famotidine

Arm Intervention/treatment
Experimental: BMS-985165-01 prototype formulation 1 Drug: BMS-986165-01
Participants will receive BMS- 986165 -01 in prototype formulation

Experimental: BMS-986165 Tablet Drug: BMS-986165 Tablet
Participants will receive BMS-986165 in tablet form.

Experimental: BMS-985165-01 prototype formulation 2 Drug: BMS-986165-01
Participants will receive BMS- 986165 -01 in prototype formulation

Experimental: BMS-985165-01 prototype formulation 3 Drug: BMS-986165-01
Participants will receive BMS- 986165 -01 in prototype formulation

Experimental: BMS-985165-01 prototype formulation 3 or 4 Drug: BMS-986165-01
Participants will receive BMS- 986165 -01 in prototype formulation

Drug: Famotidine
Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

Experimental: BMS-985165-01 prototype formulation 3, 4 or 5 Drug: BMS-986165-01
Participants will receive BMS- 986165 -01 in prototype formulation

Drug: Famotidine
Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  2. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165 [ Time Frame: Day 1 of treatment ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165 [ Time Frame: Day 1 of treatment ]

Secondary Outcome Measures :
  1. Time to maximum observed plasma concentration-(Tmax) for BMS -986165 [ Time Frame: Day 1 of treatment ]
  2. Apparent plasma elimination half-life- (T-HALF) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  3. Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  4. Apparent clearance -(CL/F) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  5. Concentration observed at 24 hours-(C24) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  6. Concentration observed at 12 hours-(C12) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  7. Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy. [ Time Frame: Approximately 16 weeks ]
  8. Incidence of serious adverse events (SAE) leading to discontinuation of study therapy. [ Time Frame: Approximately 16 weeks. ]
  9. Incidence of adverse events (AEs) leading to discontinuation of study therapy. [ Time Frame: Approximately 16 weeks. ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Patients must be willing and able to complete all study-specific procedures and visits
  • Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
  • Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
  • Normal renal function at screening

Exclusion Criteria:

  • History or presence of chronic bacterial, viral infection, or autoimmune disorder
  • Active TB requiring treatment or documented latent TB within the previous 3 years
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
  • WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04065932     History of Changes
Other Study ID Numbers: IM011-020
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs