A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects

NCT03135509 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-220-CP-005U1111-1195-6929
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions. Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The sequences will dictate the order in which each subject receives the following treatments:

• Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules.
• Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.

Conditions

Healthy Volunteers

Keywords

Healthy Subjects; CC-220 Capsules; Relative Bioavailability; Phase 1

Outcome Measures

Primary Outcomes (2)

• PK - Cmax

  Observed maximum plasma concentration

  Up to approximately 1 month

• PK - AUC0-t

  Area under the concentration-time curve calculated from time zero to the last measured time point

  Up to approximately 1 month

Secondary Outcomes (1)

• Adverse Events (AEs)

  Up to approximately 1 month

Study Arms (2)

Treatment A (Reference)- CC-220 gelatin capsules

EXPERIMENTAL

A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules.

Drug: CC-220

Treatment B (Test)- CC-220 HPMC capsule

EXPERIMENTAL

A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 hydroxypropyl methylcellulose (HPMC) capsule.

Drug: CC-220

Interventions

CC-220 DRUG

CC-220 gelatin capsules

Treatment A (Reference)- CC-220 gelatin capsules; Treatment B (Test)- CC-220 HPMC capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 18 and ≤ 65 years of age at the time of signing the Informed Consent Form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is in good health, as determined by the Investigator based on a Physical examination (PE) at screening.
• Subject agrees to abide by the requirements and restrictions outlined in the CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
• Female subjects NOT of childbearing potential must:
• a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening).
• Male subjects must:
• a. Practice true abstinence1 (which must be reviewed on a monthly basis, as applicable, and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms are recommended\]) during sexual contact with a pregnant female or female of childbearing potential (FCBP)2 while participating in the study, during dose interruptions, and for at least 90 days after the last dose of investigational product (IP), even if he has undergone a successful vasectomy.
• Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
• Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
• Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
• Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
• If male, subject has a QTcF value ≤ 430 msec at screening.

You may not qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 18 and ≤ 65 years of age at the time of signing the Informed Consent Form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is in good health, as determined by the Investigator based on a Physical examination (PE) at screening.
• Subject agrees to abide by the requirements and restrictions outlined in the CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
• Female subjects NOT of childbearing potential must:
• a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle- stimulating hormone \[FSH\] level of \> 40 IU/L at screening).
• Male subjects must:
• a. Practice true abstinence1 (which must be reviewed on a monthly basis, as applicable, and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms are recommended\]) during sexual contact with a pregnant female or female of childbearing potential (FCBP)2 while participating in the study, during dose interruptions, and for at least 90 days after the last dose of investigational product (IP), even if he has undergone a successful vasectomy.
• Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
• Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
• Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
• Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
• If male, subject has a QTcF value ≤ 430 msec at screening.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Quintiles Phase One Services, LLC

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

iberdomide

Study Officials

• Maria Palmisano, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 1, 2017
• Study Start: May 24, 2017
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)