Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-99677 in Healthy Adult Japanese Participants.

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC 99677 in Healthy Adult Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958291
• Other study ID #: CC-99677-CP-004
• Status: Completed
• Phase: Phase 1
• Start date: August 3, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: November 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy Japanese adult participants. This study will be placebo-controlled to appropriately characterize the safety and tolerability of CC-99677.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 7, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

1. Participant is = 18 and = 55 years of age at the time of signing the informed consent form (ICF).

2. Japanese participants must have both paternal and both maternal grandparents be ethnically Japanese.

3. Participants must adhere to protocol-specified contraception requirements.

4. Participant has a body mass index (BMI) = 18 and = 33 kg/m2 at screening.

5. Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

1. Participant has any significant medical condition (including but not limited to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.

2. Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.

3. Participant is pregnant or breastfeeding.

4. Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).

5. Participant has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days prior to the first dose administration. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to by the Investigator and Sponsor's Medical Monitor.

6. Participant has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to by the Investigator and Sponsor's Medical Monitor.

7. Participant has used CYP3A inducers and/or inhibitors (including St. John's Wort) within 30 days preceding the first dose administration.

8. Participant has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, or excretion, e.g., bariatric procedure. Appendectomy and cholecystectomy are acceptable. Other previous surgeries may be acceptable with concurrence of the Sponsor's Medical Monitor.

9. Participant donated blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.

10. Participant smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).

11. Participant has received immunization with a live or live attenuated vaccine within 2 months prior to the first dose administration or is planning to receive immunization with a live or live attenuated vaccine for 2 months following the last dose administration.

12. Participant has a history of Gilbert's syndrome or has laboratory findings at screening that, in the opinion of the Investigator, are indicative of Gilbert's syndrome.

13. Participant has a history of incompletely treated Mycobacterium tuberculosis (TB) infection, or has a positive QuantiFERON®-TB Gold (or equivalent) test at screening or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) tests at screening.

14. Participants with clinical symptoms or signs (including febrile illness) suggesting active, subacute, or unresolved chronic infection.

15. Previous SARS-CoV-2 infection within 4 weeks prior to screening.

a. Symptoms must have completely resolved and, based on Investigator assessment in consultation with the Sponsor's Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving IP.

16. Participant has previously been exposed to CC-99677 (e.g., in a prior clinical trial).

17. Participant has a history of photosensitivity to medications.

18. Participant is part of the study site staff personnel or a family member of the study site staff.

19. Any other exclusion criteria specified in the protocol that will be made known to participants prior to signing ICF.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CC-99677
CC-99677

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Local Institution - 001	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.	From enrollment until at least 28 days after last dose of study treatment
Secondary	Pharmacokinetics - Cmax for CC-99677	Maximum observed plasma concentration within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - tmax for CC-99677	Time of maximum observed plasma concentration within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AUCtau for CC-99677	Area under the plasma concentration-time curve within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AUC0-ti for CC-99677	Area under the plasma concentration-time curve from time zero to time ti within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Ctau for CC-99677	Concentration at the end of a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Ctrough for CC-99677	Trough observed plasma concentration	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - t½ for CC-99677	Apparent terminal phase half-life	Up to 48 hours after last dose of study treatment
Secondary	Apparent terminal phase half-life	Apparent total body clearance	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Vz/F for CC-99677	Apparent volume of distribution of terminal phase	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - DF for CC-99677	Degree of fluctuation	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Css-avg for CC-99677	Average concentration within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AI_Cmax for CC-99677	Ratio of Cmax at steady-state to Cmax after the first dose	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AI_AUC for CC-99677	Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Cmax for CC0782951	Maximum observed plasma concentration within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - tmax for CC0782951	Time of maximum observed plasma concentration within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AUCtau for CC0782951	Area under the plasma concentration-time curve within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AUC0-ti for CC0782951	Area under the plasma concentration-time curve from time zero to time ti within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Ctau for CC0782951	Concentration at the end of a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Ctrough for CC0782951	Trough observed plasma concentration	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - t½ for CC0782951	Apparent terminal phase half-life	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - DF for CC0782951	Degree of fluctuation	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - Css-avg for CC0782951	Average concentration within a dosing interval	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AI_Cmax for CC0782951	Ratio of Cmax at steady-state to Cmax after the first dose	Up to 48 hours after last dose of study treatment
Secondary	Pharmacokinetics - AI_AUC for CC0782951	Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose	Up to 48 hours after last dose of study treatment

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls