CompletedNCT03254784Updated Feb 25, 2020

A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

A Phase 1 interventional study of BMS-986165 Capsule and BMS-986165 Tablet in Systemic Lupus Erythematosus, Arthritic Psoriasis and Psoriasis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 49
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.

Conditions studied

Systemic Lupus Erythematosus
Arthritic Psoriasis
Psoriasis
Inflammatory Bowel Diseases

Browse trials for

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion Criteria:

Women of childbearing potential not using an effective contraceptive method or are breastfeeding
Any significant acute or chronic medical illness
History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
History of headaches related to caffeine withdrawal, including energy drinks
History of syncope, orthostatic instability, or recurrent dizziness
Active TB requiring treatment or documented latent TB within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 49 participants (actual)

Study arms

Experimental
Tablet-Capsule Crossover 1
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule · Drug: BMS-986165 Tablet
Experimental
Tablet-Capsule Crossover 2
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule · Drug: BMS-986165 Tablet
Experimental
Tablet-Capsule Crossover 3
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule · Drug: BMS-986165 Tablet
Experimental
Tablet-Capsule Crossover 4
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule · Drug: BMS-986165 Tablet
Experimental
Tablet-Capsule Crossover 5
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule · Drug: BMS-986165 Tablet
Experimental
Tablet-Capsule Crossover 6
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule · Drug: BMS-986165 Tablet

Interventions

DrugBMS-986165 Capsule
Oral capsule
DrugBMS-986165 Tablet
Oral tablet

What researchers measure

Primary outcomes

Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
Time frame: 5 days
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
Time frame: 5 days
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time
Time frame: 5 days
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
Time frame: 5 days

Secondary outcomes

Adverse events measured by incidence
Time frame: 26 days
Serious adverse events measured by incidence
Time frame: Approximately 55 days

Study locations

1 site

PRA Health Sciences
Lenexa, Kansas 66219, United States

References and documents

Registry details

Key details

Study ID: NCT03254784
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Aug 18, 2017
Start date: Sep 13, 2017
Primary completion: Nov 4, 2017
Completion: Nov 15, 2017
Last update: Feb 25, 2020

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis, Psoriatic→

Other studies from this sponsor