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Completed

NCT Number: NCT04065932

A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

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

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Key information

Conditions

Lupus

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

BMS-986165-01

Drug

Participants will receive BMS- 986165 -01 in prototype formulation

BMS-986165 Tablet

Drug

Participants will receive BMS-986165 in tablet form.

Famotidine

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2019
Registry last updated
Jan 6, 2021

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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