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Immunosuppression For DiseasePhase 1NCT02068053

Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020

A Phase 1 study testing [14C] BMS-986020 in people with Immunosuppression For Disease, run by Bristol-Myers Squibb.

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 purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, as well as safety and tolerability of a single oral solution dose of [14C] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Immunosuppression For Disease
What is being tested?
[14C] BMS-986020
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
Mar 2014to Apr 2014
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 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body weight of at least 50 kg (110 lbs), Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. Body mass index = weight (kg)/[height(m)]2
  • Men, ages 18 to 50 years, inclusive
  • Men who are sexually active with women of childbearing potential (WOCBP) (except those with vasectomy with documented azoospermia 90 days after procedure) must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the investigational drug (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days post-treatment completion

Who cannot join

  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • Current or recent history of constipation or irregular bowel movements (less than once per 2 days)
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
  • History of Gilbert's Syndrome
Show all 13Show fewer
  • Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
  • Blood transfusion within 4 weeks of study drug administration
  • Inability to tolerate oral medication
  • Inability to be venipunctured and/or tolerate venous access
  • Recent (within 6 months of study drug administration) history of smoking
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
  • History of allergy to LPA1 antagonists or related compounds

About this study

Official title: Pharmacokinetics and Metabolism of [14C] BMS-986020 in Healthy Male Subjects

The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, as well as safety and tolerability of a single oral solution dose of [14C] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.

Read the detailed description

Primary purpose: Other - This study will investigate the pharmacokinetic, biotransformation, routes of elimination, and mass balance of BMS-986020 in humans. The knowledge of the routes of elimination of the drug and its metabolites is useful for evaluating the likelihood of effects of renal or hepatic impairment on the disposition of BMS-986020

Being tested
[14C] BMS-986020

What participants receive

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

  • [14C] BMS-986020Drug

    Also called Lysophosphatidic Acid receptor 1 (LPA1) Antagonist

Study groups in NCT02068053
Study groupRoleWhat they receive
Arm A - BMS-986020Experimental600 mg (approximately 80 micro Curie) of [14C] BMS-986020 Single Dose for 1 Day (Day 1) orally
Receives: Drug: [14C] BMS-986020

What is being measured

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

  1. Maximum observed plasma concentration (Cmax) of BMS-986020 and Total Radioactivity (TRA)

    Measured: 22 Timepoints up to Day 11

  2. Time of maximum observed plasma concentration (Tmax) of BMS-986020 and TRA

    Measured: 22 Timepoints up to Day 11

  3. Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-986020 and TRA

    Measured: 22 Timepoints up to Day 11

  4. Area under the concentration time curve from time zero to 168 hours postdose (AUC(0-168)) of BMS-986020 and TRA

    Measured: 19 Timepoints up to Day 8

  5. Area under the concentration time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986020 and TRA

    Measured: 22 Timepoints up to Day 11

  6. Terminal plasma half-life (T-Half) of BMS-986020 and TRA

    Measured: 22 Timepoints up to Day 11

  7. Apparent total body clearance (CL/F) of BMS-986020

    Measured: 19 Timepoints up to Day 8

  8. Percent of plasma BMS-986020 AUC(0-T) (%AUC(0-T)) relative to plasma TRA AUC(0-T)

    Measured: 22 Timepoints up to Day 11

  9. Percent of plasma BMS-986020 AUC(INF) (%AUC(INF)) relative to plasma TRA AUC(INF)

    Measured: 22 Timepoints up to Day 11

  10. Percent of total administered radioactivity excreted in urine (% UR)

    Measured: 13 Timepoints up to Day 11

  11. Percent of total administered radioactivity excreted in feces (% FE)

    Measured: 11 Timepoints up to Day 11

  12. Percent of total administered radioactivity recovered in urine and feces (%TOTAL)

    Measured: 13 Timepoints up to Day 11

Secondary outcomes (5)

  1. Incidence of Adverse Event (AE)s collected during the study will be reviewed for potential significance and clinical importance

    Measured: Upto Day 11

  2. Clinical laboratory test results: Safety laboratory testing will be drawn at specified times

    Measured: Up to Day 11

  3. Vital Signs: Blood pressure, heart rate, respiratory rate, and body temperature measurements will be assessed at specified time points

    Measured: Up to Day 11

  4. Electrocardiogram (ECG): Regular ECG endpoints (heart rate, PR interval, QRS interval, and QT intervals corrected for heart rate) and investigator identified abnormalities will be assessed at the time points

    Measured: Up to Day 11

  5. Physical examinations: Physical examinations will be assessed at the time points

    Measured: Up to Day 11

Timeline

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

  1. First posted20 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionApr 2014
  4. Study completionApr 2014

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02068053
Sponsor's protocol ID
IM136-006
Status last verified
May 2014
First submitted
19 Feb 2014
Last updated
2 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] BMS-986020 in people with Immunosuppression For Disease, run by Bristol-Myers Squibb.

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 4 inclusion and 13 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 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Maximum observed plasma concentration (Cmax) of BMS-986020 and Total Radioactivity (TRA) (time frame: 22 Timepoints up to Day 11). The study lists 12 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 NCT02068053.

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 2 Jun 2014.

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