A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03378310
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BMS-986205 reference tablet; Drug: BMS-986205 tablet with free base	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label Study to Evaluate the Bioavailability of a BMS-986205 Tablet Containing Free Base Relative to a Reference Tablet in Healthy Participants
• Actual Study Start Date: Dec 21, 2017
• Actual Primary Completion Date: Feb 15, 2018
• Actual Study Completion Date: Feb 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reference tablet followed by BMS-986205 tablet with free base BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).	Drug: BMS-986205 reference tablet; Single, 100 mg oral dose.; Drug: BMS-986205 tablet with free base; Single, 100 mg oral dose.
Experimental: BMS-986205 tablet with free base followed by reference tablet BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).	Drug: BMS-986205 reference tablet; Single, 100 mg oral dose.; Drug: BMS-986205 tablet with free base; Single, 100 mg oral dose.

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet. [Up to Day 22]

   Measured by plasma concentration.

2. Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet. [Up to Day 22]

   Measured by plasma concentration.

Secondary Outcome Measures

1. Incidence of non-serious Adverse Events (AEs). [Up to Day 22]

   Safety and tolerability as measured by incidence of non-serious AEs.

2. Incidence of Serious Adverse Events (SAEs). [Up to Day 22]

   Safety and tolerability as measured by incidence of SAEs.

3. Incidence of Adverse Events (AEs) leading to discontinuation. [Up to Day 22]

   Safety and tolerability as measured by incidence of AEs leading to discontinuation.

4. Number of participants with vital sign abnormalities. [Up to Day 22]

5. Number of participants with electrocardiogram (ECG) abnormalities. [Up to Day 22]

6. Number of participants with clinical laboratory abnormalities. [Up to Day 22]

7. Number of participants with physical examination abnormalities. [Up to Day 22]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed, written informed consent.

• Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.

• Normal renal (kidney) function.

• Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.

• Women must have documented proof they are not of childbearing potential.

• Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

• Women of childbearing potential or breastfeeding.

• Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.

• History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.

• Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.

• Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Austin Clinic	Austin	Texas	United States	78744

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03378310
• Other Study ID Numbers: CA017-069
• First Posted: Dec 19, 2017
• Last Update Posted: Feb 28, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Linrodostat

Study Results

No Results Posted as of Feb 28, 2018