Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

NCT03044873 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.

Conditions

Autoimmune Diseases; Inflammatory Diseases

Outcome Measures

Primary Outcomes (3)

• Cmax (Maximum observed plasma concentration) of Rosuvastatin.

  Measured by plasma concentration.

  Up to Day 13

• AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin.

  Measured by plasma concentration.

  Up to Day 13

• AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.

  Measured by plasma concentration.

  Up to Day 13

Secondary Outcomes (4)

• Number of Subjects with Deaths.

  Up till 30 days after discontinuation

• Number of Subjects with Serious Adverse Events.

  Up till 30 days after discontinuation

• Number of Subjects with Adverse Events.

  Up till 30 days after discontinuation

• Number of subjects with Adverse Events Leading to Discontinuation.

  Up till 30 days after discontinuation

Study Arms (1)

BMS 986165 and Rosuvastatin

EXPERIMENTAL

Drug: BMS-986165; Drug: Rosuvastatin

Interventions

BMS-986165 DRUG

Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.

BMS 986165 and Rosuvastatin

Rosuvastatin DRUG

Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.

BMS 986165 and Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent
• Healthy male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
• Subjects with body mass index of 18 to 32 kg/m2, inclusive.
• Women participants must have documented proof that they are not of childbearing potential.
• Men who are sexually active with WOCBP must agree to follow instructions for method(s) of highly effective contraception for the duration of study treatment(s) plus 5 half-lives of BMS-986165 (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days of post BMS-986165 treatment. In addition, male participants must be willing to refrain from sperm donation during this time.

You may not qualify if:

• History of allergy to BMS-986165, rosuvastatin, or related compounds, of myalgia or rhabdomyolysis while taking rosuvastatin or related compounds or any other drug allergy
• Any significant acute or chronic medical illness, active TB requiring treatment or documented latent TB within the previous 3 years, current or recent gastrointestinal disease, current or recent history of nausea, vomiting, constipation or irregular bowel movement
• History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
• Smokers who currently smoke, recent drug or alcohol abuse, blood transfusion within 4 weeks of study treatment administration, current skin findings that could interfere with the interpretation of study

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

Related Links

• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

deucravacitinib; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: February 2, 2017
• Primary Completion: March 14, 2017
• Study Completion: March 27, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

US (1)