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A First-in-Human Study to Assess Single and Multiple Doses of BMS-986209 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154800
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study investigates the safety and tolerability of drug BMS-986209 in healthy volunteers. It also looks at the movement of BMS-986209 in the body. This first-in-human study is designed in 2 parts. In Part A, healthy participants will take a single, oral dose of BMS-986209 or placebo. Food effect will also be assessed in Part A. Part A participants may be at the study site for up to 5 days. In Part B, healthy participants will take either a once- or twice-daily oral dose of BMS-986209 or placebo for 14 days. Part B participants may be at the study site for up to 19 days.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BMS-986209 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Active Comparator: Part A: Fasting
Single ascending dose (SAD).
Drug: BMS-986209
Oral administration

Drug: Placebo
Oral administration

Active Comparator: Part A: Fed
Single Ascending Dose (SAD)
Drug: BMS-986209
Oral administration

Drug: Placebo
Oral administration

Active Comparator: Part B: Fasting
Multiple Ascending Dose (MAD)
Drug: BMS-986209
Oral administration

Drug: Placebo
Oral administration

Active Comparator: Part B: Fed
Multiple Ascending Dose (MAD)
Drug: BMS-986209
Oral administration

Drug: Placebo
Oral administration




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: Day 81 ]
  2. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Day 81 ]
  3. Number of Participants with AEs resulting in Study Discontinuation [ Time Frame: Day 81 ]
  4. Number of Participants with Vital Sign Abnormalities [ Time Frame: Day 81 ]
  5. Number of Participants with Electrocardiogram (ECG) Abnormalities [ Time Frame: Day 81 ]
  6. Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Day 81 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. (BMI = weight (kg)/height[m])2.
  • Normal renal function at screening.
  • Female participants not of child-bearing potential.
  • Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception: to use a condom during the intervention period and for at least 92 days after the last dose of study intervention. Azoospermic males are exempt from contraceptive requirements.
  • Males with a pregnant or breastfeeing partner must agree to remain abstinent from penile vaginal intercourse or use a male condom during each episode of such intercourse, during the intervention period and for at least 92 days after the last dose of study intervention.
  • Male participants must refrain from donating sperm during the intervention period and for at least 92 days after the last dose of study intervention.

Exclusion Criteria:

  • Women who are of childbearing potential.
  • Women who are breastfeeding.
  • Any acute or chronic medical illness.
  • History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for a 1-week duration in the last month prior to study treatment administration).
  • History of heart disease or conduction disorders.
  • Head injury in the last 2 years, intracranial tumor, or aneurysm.
  • Current or history of rectal bleeding, hematemesis, or hematuria.
  • Known abdominal aneurysm.
  • History of gastroesophageal reflux disease, inflammatory bowel disease or any gastrointestinal disease that could impact the absorption of study treatment.
  • History or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such as epistaxis.
  • Personal or family history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
  • History of systemic lupus erythematosus or any other autoimmune diseases.
  • Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.
  • Donation of blood to a blood bank or in a clinical study (except a screening visit or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only).
  • Current or any history of blood transfusion.
  • Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration).
  • Current or history of drug or alcohol abuse.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154800


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT# and Site #

Locations
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United States, Texas
Local Institution
Austin, Texas, United States, 78744
Contact: Site 001         
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04154800    
Other Study ID Numbers: CV017-003
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Healthy Volunteers