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Healthy VolunteersPhase 1NCT05099822

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants

A Phase 1 study testing CC-97489 in people with Healthy Volunteers, run by Celgene at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to evaluate the safety, tolerability, of CC-97489 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
CC-97489
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteBelgium
Study dates
13 Mar 2020to 11 Jul 2022
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • In good health, as determined by the investigator based on past medical history, physical examination, vital signs and clinical laboratory safety tests at screening.
  • Body mass index (BMI) ≥ 18 and ≤ 33 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2

Who cannot join

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Local Institution - 001

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of CC-97489 in Healthy Adult Subjects

This study aims to evaluate the safety, tolerability, of CC-97489

Being tested
CC-97489, Placebo
Keywords
CC-97489, Healthy Adult, Phase1

What participants receive

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

  • CC-97489Drug

    Also called BMS-986368

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT05099822
Study groupRoleWhat they receive
Administration of CC-97489ExperimentalNot described
Receives: Drug: CC-97489
Administration of PlaceboExperimentalNot described
Receives: Other: Placebo

What is being measured

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

  1. Incidence of Adverse Events (AEs)

    Measured: 28 days after the last dose

  2. Incidence of Serious Adverse Events (SAEs)

    Measured: 28 days after the last dose

  3. Number of participants with clinically significant changes in electrocardiogram parameters

    Measured: Day 21

  4. Incidence of clinically significant changes in vital signs: Body temperature

    Measured: Day 21

  5. Incidence of clinically significant changes in vital signs: Respiratory rate

    Measured: Day 21

  6. Incidence of clinically significant changes in vital signs: Blood pressure

    Measured: Day 21

  7. Incidence of clinically significant changes in vital signs: Heart rate

    Measured: Day 21

  8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Measured: Day 18

  9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Measured: Day 18

  10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Measured: Day 18

Secondary outcomes (15)

  1. Pharmacokinetics - Maximum observed plasma concentration (Cmax)

    Measured: Up to 96 hours after the last dose of study drug

  2. Pharmacokinetics - Minimum plasma drug concentration (Cmin)

    Measured: Up to 96 hours after the last dose of study drug

  3. Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)

    Measured: Up to 96 hours after the last dose of study drug

  4. Pharmacokinetics - Area under the plasma concentration (AUC)-time curve from time zero extrapolated to infinity (AUC0-∞)

    Measured: Up to 96 hours after the last dose of study drug

  5. Pharmacokinetics - Area under the plasma concentration-time curve from time zero to time t, where t is the time point of the last measurable concentration (AUC0-t)

    Measured: Up to 96 hours after the last dose of study drug

  6. Pharmacokinetics - Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24)

    Measured: Up to 96 hours after the last dose of study drug

  7. Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau (τ) where τ is the dosing interval (AUC0- 0-τ)

    Measured: Up to 96 hours after the last dose of study drug

  8. Pharmacokinetics - Terminal elimination half-life in plasma (t½,z)

    Measured: Up to 96 hours after the last dose of study drug

  9. Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F)

    Measured: Up to 96 hours after the last dose of study drug

  10. Pharmacokinetics - Apparent total volume of distribution when dosed orally (Vz/F)

    Measured: Up to 96 hours after the last dose of study drug

  11. Pharmacokinetics - Ratio of accumulation based on Day 1 and Day 14 AUC0- 0-τ and Cmax, as appropriate (Rac)

    Measured: Up to 96 hours after the last dose of study drug

  12. Pharmacodynamics - Evaluation of monoacylglycerol lipase (MGLL) enzymatic inhibition by CC-97489 in peripheral blood mononuclear cells (PBMCs)

    Measured: Up to 168 hours after the last dose of study drug

  13. Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition

    Measured: Up to 168 hours after the last dose of study drug

  14. Pharmacodynamics - Measurement of : plasma and whole-blood anandamide (AEA) levels

    Measured: Up to 168 hours after the last dose of study drug

  15. Pharmacodynamics - Measurement of plasma and whole-blood 2-arachidonoylglycerol (2-AG) levels

    Measured: Up to 168 hours after the last dose of study drug

Timeline

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

  1. First posted29 Oct 2021
  2. Study start13 Mar 2020
  3. Primary completion11 Jul 2022
  4. Study completion11 Jul 2022

Why it stopped: Business objectives changed.

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099822
Sponsor's protocol ID
CC-97489-CP-001
Other IDs
2019-003458-10, 2019
Status last verified
Dec 2023
First submitted
9 Sep 2021
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-97489 in people with Healthy Volunteers, run by Celgene at 1 site in Belgium.

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 2 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: stopped early, as of the sponsor's last update on 14 Dec 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 Belgium. 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 was stopped early (reason given: Business objectives changed.). Results are not available in the source record.

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 Adverse Events (AEs) (time frame: 28 days after the last dose). The study lists 10 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 NCT05099822.

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 14 Dec 2023.

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