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Rheumatoid ArthritisPhase 1NCT02211469

A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects

A Phase 1 study testing BMS-986104 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective in this study is to assess if single doses of BMS-986104 that are safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte count) can be achieved without bradycardia or other adverse events in healthy male subjects. Read more about this study

Who is it for?
Ages 18 to 49 years, men onlyHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
BMS-986104
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited States
Study dates
Aug 2014to Jul 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
  • Men ages 18 to 49 years, inclusive

Who cannot join

  • Any acute or chronic medical illness judged to be clinically-significant by the Investigator and/or Sponsor medical monitor
  • Presence of fecal occult blood at screening
  • History of prolonged occupational exposure to organic solvents or pesticides
  • History of vitamin B12 deficiency and/or achlorhydria; or a vitamin B12 level at screening <lower limit of normal (LLN), confirmed by repeat test
  • History of Guillain-Barré Syndrome
  • Past or current history of central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesias (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities. Note: Experiencing an extremity "falling asleep" occasionally is not be exclusionary
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  • Clinically significant abnormality in the neurological exam at baseline (predose)
  • Clinically significant nerve electrophysiology abnormalities at baseline (predose)
  • Any history of testicular or epididymal disease/disorder
  • Clinically significant abnormality on ophthalmologic exam or any findings suggesting an increased risk of macular edema at baseline (predose)
  • History of hypothyroidism or carpal tunnel syndrome
  • Subjects with history of diabetes mellitus
  • Subjects with history of any type of heart disease, including ischemia, infarction, arrhythmias, hypertension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
  • Subjects with any acute or chronic bacterial, fungal or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening
  • Subjects who have received any live vaccines within 1 month of study drug administration or who plan to have a live vaccine at any time during the study
  • Positive test for tuberculosis at screening (QuantiFERON® GOLD)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit, Inc.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

The primary objective in this study is to assess if single doses of BMS-986104 that are safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte count) can be achieved without bradycardia or other adverse events in healthy male subjects.

Being tested
BMS-986104, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986104Drug

  • PlaceboDrug

Study groups in NCT02211469
Study groupRoleWhat they receive
Panel 1: BMS-986104 or PlaceboExperimentalBMS-986104 or Placebo single dose by mouth as specified
Receives: Drug: BMS-986104; Drug: Placebo
Panel 2: BMS-986104 or PlaceboExperimentalBMS-986104 or Placebo single dose by mouth as specified
Receives: Drug: BMS-986104; Drug: Placebo
Panel 3: BMS-986104 or PlaceboExperimentalBMS-986104 or Placebo single dose by mouth as specified
Receives: Drug: BMS-986104; Drug: Placebo
Panel 4: BMS-986104 or PlaceboExperimentalBMS-986104 or Placebo single dose by mouth as specified
Receives: Drug: BMS-986104; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all adverse events (AEs) / serious adverse events (SAEs)

    Measured: Up to 1 month post discharge

  2. Mean difference in ECG heart rate (HR) nadir values

    Measured: Up to 4 days postdose

  3. Nadir absolute lymphocyte count (ALC) defined as the lowest ALC measured at any time after the dose

    Measured: Up to 4 days postdose

Secondary outcomes (13)

  1. Safety and tolerability based on severity, investigator causality assessment and outcomes of all AEs (regardless of seriousness criteria), association between AEs and study drug exposure parameters, and physical examination

    Measured: Up to 1 month post discharge

  2. Mean difference in ECG HR values in BMS-986104-treated versus placebo-treated healthy male subjects, identifying nadir ECG HR

    Measured: Day -1 up to 24h and Days 1-5

  3. Percent reduction in ECG HR

    Measured: Day -1 up to 24h and Days 1-5

  4. Time to nadir ECG HR

    Measured: Day -1 up to 24h and Days 1-5

  5. Maximum observed blood concentration (Cmax) of BMS-986104

    Measured: Up to Day 56

  6. Time of maximum observed blood concentration (Tmax) of BMS-986104

    Measured: Up to Day 56

  7. Terminal half-life (T-HALF) of BMS-986104

    Measured: Up to Day 56

  8. Area under the blood concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986104

    Measured: Up to Day 56

  9. Area under the blood concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986104

    Measured: Up to Day 56

  10. Apparent total clearance (CLT/F) of BMS-986104

    Measured: Up to Day 56

  11. Apparent volume of distribution of terminal phase (Vz/F) of BMS-986104

    Measured: Up to Day 56

  12. Metabolite to parent AUC(INF) ratio [MR_AUC(INF)] for both BMS-986104 and BMT-019434

    Measured: Up to Day 56

  13. Effects of single oral doses of BMS-986104 on the following ALC

    • Time to nadir ALC from time 0h (predose)
    • Percent reduction in ALC from baseline to nadir

    Measured: Up to 4 days postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211469
Sponsor's protocol ID
IM001-001
Status last verified
Apr 2015
First submitted
6 Aug 2014
Last updated
18 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986104 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of all adverse events (AEs) / serious adverse events (SAEs) (time frame: Up to 1 month post discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02211469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.

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