NCT03873415

Brief Summary

The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

February 4, 2019

Last Update Submit

November 25, 2019

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

  • Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D

    Determined over 5 days

  • Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D

    Determined over 5 days

  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D

    Determined over 5 days

  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D

    Determined over 5 days

  • Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D

    Determined over 5 days

Secondary Outcomes (7)

  • Vital signs of body temperature

    Up to 60 days

  • Pulse rate

    Up to 60 days

  • Physical examination

    Up to 60 days

  • Incidence of adverse events (AE)

    Up to 90 days

  • Incidence of serious adverse events (SAE)

    Up to 90 days

  • +2 more secondary outcomes

Study Arms (8)

Formulation A

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation B

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation C

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation D

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation E

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation F

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation G

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Formulation H

EXPERIMENTAL

Dosage formulation and area of release varies between arms

Drug: BMS-986165

Interventions

BMS-986165DRUG

Oral administration

Formulation AFormulation BFormulation CFormulation DFormulation EFormulation FFormulation GFormulation H

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
  • Estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula

You may not qualify if:

  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
  • Acute diarrhea, or constipation within 3 weeks prior to randomization
  • Any major surgery within 4 weeks of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scintipharma

Lexington, Kentucky, 40504, United States

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

March 13, 2019

Study Start

January 25, 2019

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

US(1)