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A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986278

Pirfenidone

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Signed Informed Consent.
Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.

Exclusion Criteria:

Women of child bearing potentia (WOCBP), pregnant or breastfeeding.
History of significant cardiovascular disease.
Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study.

Other protocol defined inclusion/exclusion criteria could apply.

Sites / Locations

PRA Health Sciences - Salt Lake

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

BMS-986278

Pirfenidone

BMS-986278 + Pirfenidone

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton

Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton

Secondary Outcome Measures

Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation

Number of Participants With Clinically Significant Change in Clinical Laboratory Values

Number of Participants With Clinically Significant Change in Vital Signs

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)

Number of Participants With Clinically Significant Change in Physical Examination

Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone

Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone

Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone

Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone

Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278

Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278

Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278

Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278

Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278

Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278

Full Information

NCT ID

NCT03981094

First Posted

May 21, 2019

Last Updated

May 14, 2020

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03981094

Brief Title

A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants

Official Title

An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

July 27, 2019 (Actual)

Study Completion Date

July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis (IPF)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

The study will be conducted in three periods, so that all the randomized participants receive treatment (participants receive pirfenidone only, or BMS-986278 only, or both together during each treatment period).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-986278

Arm Type

Experimental

Arm Title

Pirfenidone

Arm Type

Experimental

Arm Title

BMS-986278 + Pirfenidone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-986278

Intervention Description

suspension

Intervention Type

Drug

Intervention Name(s)

Pirfenidone

Intervention Description

capsule

Primary Outcome Measure Information:

Title

Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination

Time Frame

Up to day 5 of each period (Each period is 7 days; 3 periods total)

Title

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton

Time Frame

Up to day 5 of each period (Each period is 7 days; 3 periods total)

Title

Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton

Time Frame

Up to day 5 of each period (Each period is 7 days; 3 periods total)

Secondary Outcome Measure Information:

Title

Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation

Time Frame

Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)

Title

Number of Participants With Clinically Significant Change in Clinical Laboratory Values

Time Frame

Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)

Title

Number of Participants With Clinically Significant Change in Vital Signs

Time Frame

Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)

Title

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)

Time Frame

Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)

Title

Number of Participants With Clinically Significant Change in Physical Examination

Time Frame

Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)

Title

Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone

Time Frame

Up to Day 5 of period 3 (each period is 7 days; 3 periods total)

Title

Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone

Time Frame

Up to Day 5 of period 3 (each period is 7 days; 3 periods total)

Title

Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone

Time Frame

Up to Day 5 of period 3 (each period is 7 days; 3 periods total)

Title

Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone

Time Frame

Up to Day 5 of period 3 (each period is 7 days; 3 periods total)

Title

Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278

Time Frame