Healthy VolunteersPhase 1NCT04965389
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
A Phase 1 study testing BMS-986177 Oral Solution, [14C]BMS-986177 Solution for Infusion and BMS-986177 Spray-dried Dispersion Capsules in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986177 Oral Solution, [14C]BMS-986177 Solution for Infusion and BMS-986177 Spray-dried Dispersion Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2021to 1 Oct 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height [m])²
Who cannot join
- History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months, intracranial bleeding, tumor, aneurysms
- History or evidence of abnormal bleeding 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, or family history of coagulopathies
- Any acute or chronic medical illness considered clinically significant by the investigator
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, neurological or psychiatric disorder, as judged by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants With Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules
The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986177 Oral Solution, [14C]BMS-986177 Solution for Infusion, BMS-986177 Spray-dried Dispersion Capsules
- Keywords
- Bioavailability, BMS-986177, 14C-Microtracer, Milvexian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986177 Oral SolutionDrug
Also called Milvexian, JNJ-70033093
Specified dose on specified days
[14C]BMS-986177 Solution for InfusionDrug
Specified dose on specified days
BMS-986177 Spray-dried Dispersion CapsulesDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Not described Receives: Drug: BMS-986177 Oral Solution; Drug: [14C]BMS-986177 Solution for Infusion; Drug: BMS-986177 Spray-dried Dispersion Capsules |
| Treatment Sequence 2 | Experimental | Not described Receives: Drug: BMS-986177 Oral Solution; Drug: [14C]BMS-986177 Solution for Infusion; Drug: BMS-986177 Spray-dried Dispersion Capsules |
| Treatment Sequence 3 | Experimental | Not described Receives: Drug: BMS-986177 Oral Solution; Drug: [14C]BMS-986177 Solution for Infusion; Drug: BMS-986177 Spray-dried Dispersion Capsules |
| Treatment Sequence 4 | Experimental | Not described Receives: Drug: BMS-986177 Oral Solution; Drug: [14C]BMS-986177 Solution for Infusion; Drug: BMS-986177 Spray-dried Dispersion Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Bioavailability (F)
Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Secondary outcomes (22)
Number of Participants Experiencing Adverse Events (AEs)
The number of participants experiencing AEs following single oral and IV administration. AEs are defined as any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)
Number of Participants Experiencing Serious Adverse Events (SAE)
The number of participants experiencing SAEs following single oral and IV administration. SAEs are defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or causes prolongation of existing hospitalization.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)
Number of Participants Experiencing Abnormal Vital Sign Measurements
Occurrence of abnormalities in vital sign measurements exceeding pre-defined thresholds following single oral and IV administration. The pre-defined thresholds include:
Heart Rate(bpm) Value > 100 and change from baseline > 30, or Value < 55 and change from baseline < -15 Systolic Blood Pressure(mmHg) Value > 140 and change from baseline > 20, or Value < 90 and change from baseline < -20 Diastolic Blood Pressure(mmHg) Value > 90 and change from baseline > 10, or Value < 55 and change from baseline < -10 Respiratory Rate(breaths/min) Value > 16 or change from baseline > 10 Temperature (°C) Value > 38.3°C or change from baseline > 1.6°C
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Number of Participants With Abnormal Electrocardiograms (ECGs)
The number of participants with abnormal findings on ECGs following single oral and IV administration. Participants with ECG intervals outside of a pre-specified range and investigator identified ECG abnormalities will be listed. The following criteria will be used to determine ECG results that are outside of a pre-specified range:
PR (msec)-Value > 200; QRS (msec)-Value > 120; QT (msec)-Value > 500 or change from baseline > 30; QTcF (msec)-Value > 450 or change from baseline > 30
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Number of Participants With Abnormal Physical Examinations
The number of participants with abnormal findings on physical examinations following single oral and IV administration.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Number of Participants With Clinical Laboratory Test Abnormalities
Number of participants with abnormalities in clinical lab test measurements exceeding pre-defined thresholds following single oral and IV administration. The pre-defined thresholds include:
Alanine transaminase > 3 × upper limit of normal (ULN) Aspartate transaminase > 3 × ULN Alkaline phosphatase > 1.5 × ULN Total bilirubin > 2 × ULN
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration following single administration in the fed and fasted states to healthy participants.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Time of Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as the time of maximum observed plasma concentration in the fed and fasted states to healthy participants.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration following single administration in the fed and fasted states to healthy participants.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(INF)]
AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity following single administration in the fed and fasted states to healthy participants
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Apparent Clearance of Drug After Extravascular Administration (CLT/F)
CLT/F is defined as the apparent clearance of drug after extravascular administration.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Renal Clearance (CLR)
CLR is defined as the volume of plasma completely cleared of a substance by the kidneys per unit of time, in this case by hour.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F)
Vz/F is defined as the apparent volume of distribution at terminal phase after extravascular administration.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Total Amount of Unchanged Drug Excreted Into the Urine (Ae)
Ae is defined as the total amount of unchanged drug excreted into the urine following single administration in the fed and fasted states to healthy participants
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Total Percent Urinary Recovery (%UR)
%UR is defined as a percent or absolute amount of dose that is recovered in the urine as the unchanged drug.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Half-life (T-HALF)
T-HALF is defined as the time required for half the quantity of a drug to be metabolized or eliminated by normal biological processes.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Mean Residence Time (MRT) Following an IV Dose in Treatment A
Mean residence time (MRT) represents the average time the drug stays in the body and is evaluated for the IV dose of Treatment A only.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Volume of Distribution at Steady State (Vss) Following an IV Dose in Treatment A
Characterize the IV dose of Treatment A by Vss, which is defined as the apparent volume of distribution at steady state
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Relative Bioavailability (Frel) Based on Ratios of Cmax
Point estimates and 90% CI for the ratio of geometric means for Cmax will be constructed for the comparison of each milvexian capsule treatment (Treatments B, C, D, and E) separately versus the oral solution (Treatment A). No data is reported for Treatment A because it is the comparison treatment.
Relative bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to a different formulation (non-IV) such as an oral solution. Cmax is defined as the maximum observed plasma concentration.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Relative Bioavailability (Frel) Based on Ratios of AUC(0-T) and AUC(INF)
Point estimates and 90% CI for the ratio of geometric means for AUC(0-T) and AUC(INF) will be constructed for the comparison of each milvexian capsule treatment (Treatments B, C, D, and E) separately versus the oral solution (Treatment A). No data is reported for Treatment A because it is the comparison treatment.
Relative bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to a different formulation (non-IV) such as an oral solution. AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Food Effect Based on Ratios of Cmax Following an SDD Capsule Dose in Treatment B, C, D, and E
Food effect analysis of the high and low dose SDD capsules based on ratios of Cmax. The food effect analysis will be run separately for each dose level. For the low dose level, low dose milvexian SDD fed (Treatment C) is the test treatment and low dose milvexian SDD fasted (Treatment D) is the reference treatment. For the high dose dose level, high dose milvexian SDD fed (Treatment E) is the test treatment and high dose milvexian SDD fasted (Treatment B) is the reference treatment.
Cmax is defined as the maximum observed plasma concentration.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Food Effect Based on Ratios of AUC(0-T) and AUC(INF) Following an SDD Capsule Dose in Treatment B, C, D, and E
Food effect with low and high dose SDD capsules based on ratios of AUC(0-T) and AUC(INF). The food effect analysis will be run separately for each dose level. For the low dose level, low dose milvexian SDD fed (Treatment C) is the test treatment and low dose milvexian SDD fasted (Treatment D) is the reference treatment. For the high dose level, high dose milvexian SDD fed (Treatment E) is the test treatment and high dose milvexian SDD fasted (Treatment B) is the reference treatment.
AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity.
Measured: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start16 Jul 2021
- Primary completion22 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965389
- Sponsor's protocol ID
- CV010-062
- Other IDs
- 2021-000892-35
- Status last verified
- Sep 2022
- First submitted
- 7 Jul 2021
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants With Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules
- ClinicalTrials.gov ID
- NCT04965389
- Acronym / sponsor ID
- CV010-062
- Conditions
- Healthy Volunteers
- Keywords
- Bioavailability, BMS-986177, 14C-Microtracer, Milvexian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 22 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: BMS-986177 Oral Solution, Drug: [14C]BMS-986177 Solution for Infusion, Drug: BMS-986177 Spray-dried Dispersion Capsules |
| Treatment Sequence 2 | Experimental | Drug: BMS-986177 Oral Solution, Drug: [14C]BMS-986177 Solution for Infusion, Drug: BMS-986177 Spray-dried Dispersion Capsules |
| Treatment Sequence 3 | Experimental | Drug: BMS-986177 Oral Solution, Drug: [14C]BMS-986177 Solution for Infusion, Drug: BMS-986177 Spray-dried Dispersion Capsules |
| Treatment Sequence 4 | Experimental | Drug: BMS-986177 Oral Solution, Drug: [14C]BMS-986177 Solution for Infusion, Drug: BMS-986177 Spray-dried Dispersion Capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height [m])²
Key exclusion criteria (5 listed)
- History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months, intracranial bleeding, tumor, aneurysms
- History or evidence of abnormal bleeding 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, or family history of coagulopathies
- Any acute or chronic medical illness considered clinically significant by the investigator
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, neurological or psychiatric disorder, as judged by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986177 Oral SolutionAlso: Milvexian, JNJ-70033093Specified dose on specified days | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| [14C]BMS-986177 Solution for InfusionSpecified dose on specified days | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| BMS-986177 Spray-dried Dispersion CapsulesSpecified dose on specified days | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
Absolute Bioavailability (F)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).
22 secondary outcomes
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)
Number of Participants Experiencing Abnormal Vital Sign Measurements
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Number of Participants With Abnormal Electrocardiograms (ECGs)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Number of Participants With Abnormal Physical Examinations
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Number of Participants With Clinical Laboratory Test Abnormalities
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(INF)]
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Apparent Clearance of Drug After Extravascular Administration (CLT/F)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Renal Clearance (CLR)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Total Amount of Unchanged Drug Excreted Into the Urine (Ae)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Total Percent Urinary Recovery (%UR)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Half-life (T-HALF)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Mean Residence Time (MRT) Following an IV Dose in Treatment A
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Volume of Distribution at Steady State (Vss) Following an IV Dose in Treatment A
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Relative Bioavailability (Frel) Based on Ratios of Cmax
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Relative Bioavailability (Frel) Based on Ratios of AUC(0-T) and AUC(INF)
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Food Effect Based on Ratios of Cmax Following an SDD Capsule Dose in Treatment B, C, D, and E
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Food Effect Based on Ratios of AUC(0-T) and AUC(INF) Following an SDD Capsule Dose in Treatment B, C, D, and E
Time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986177 Oral Solution, [14C]BMS-986177 Solution for Infusion and BMS-986177 Spray-dried Dispersion Capsules in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 5 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 21 Aug 2023. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Bioavailability (F) (time frame: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.