A Study to Evaluate Effects of CC-99677 on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Participants

NCT04718636 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-99677-CP-003U1111-1258-2701
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of CC-99677 coadministration on the pharmacokinetics (PK) of an oral contraceptive (OC).

Conditions

Healthy Volunteers

Keywords

Healthy Female Volunteers; CC-99677; Contraceptive

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetic - AUC0-τ

  The area under the curve (AUC) for the defined interval between doses (TAU)

  Up to 36 hours post-dose

• Pharmacokinetic - AUC0-t

  The area under the curve (AUC) from the time of dosing to the last measurable concentration

  Up to 36 hours post-dose

• Pharmacokinetic - Cmax

  Maximum observed plasma concentration occurring at Tmax

  Up to 36 hours post-dose

• Pharmacokinetic - Tmax

  The time of maximum observed concentration sampled during a dosing interval

  Up to 36 hours post-dose

• Pharmacokinetic - t1/2

  Terminal half-life

  Up to 36 hours post-dose

• Pharmacokinetic - CL/F

  The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration

  Up to 36 hours post-dose

• Pharmacokinetic - Vz/F

  The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration

  Up to 36 hours post-dose

Secondary Outcomes (1)

• Adverse Events (AEs)

  From enrollment until at least 28 days after completion of study treatment

Study Arms (1)

Administration of OC alone, then progress to OC in combination with CC-99677

EXPERIMENTAL

Oral Contraceptive (OC) and CC-99677 will be administered daily

Drug: Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent); Drug: CC-99677

Interventions

Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) DRUG

Daily

Administration of OC alone, then progress to OC in combination with CC-99677

CC-99677 DRUG

Daily

Administration of OC alone, then progress to OC in combination with CC-99677

Eligibility Criteria

• Age: 18 Years - 48 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must satisfy all of the following criteria to be eligible for enrollment into the study:
• Participant is ≥ 18 and ≤ 48 years of age at the time of signing the informed consent form (ICF).
• Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
• Participant is in good health, as determined by the Investigator based on a physical examination at screening.
• Participant has a body mass index (BMI = weight \[kg\]/(height \[m\])2) between 18 and 30 kg/m2 (inclusive).
• Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline as verified by the Investigator prior to the first dose of IP. She must agree to ongoing pregnancy testing during the course of the study, and prior to discharge from the study site. This applies even if the FCBP participant practices true abstinence from heterosexual contact.
• FCBP must either commit to true abstinence from heterosexual contact (which must be reviewed on a weekly basis, as applicable, and source documented) or agree to use, and be able to comply with, highly effective methods of contraception without interruption, during the study (including any dose interruptions), and for at least 28 days after discontinuation of IP.
• If previously taking a hormonal OC, she must agree to continue using (or switch over to, if applicable) Ortho Tri-Cyclen® or its generic equivalent, which is to be provided by the study center, throughout the study.
• Female participants NOT of childbearing potential must:
• Have been surgically sterilized (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; proper documentation is 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).
• Participant has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator. In addition, ALT, AST, and total bilirubin must be less than the upper limit of normal at screening and on Day -1.
• Participant 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.
• Participant has normal or clinically acceptable 12 lead ECG with a QTcF value ≤ 450 msec at screening.

You may not qualify if:

• The presence of any of the following will exclude a participant from enrollment:
• Participant has any significant medical condition (including but not limited to gynecologic, infectious, oncologic, 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.
• 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 according to the Investigator or Sponsor.
• Participant has any condition that confounds the ability to interpret data from the study.
• Pregnant, breast-feeding, or \< 6 months postpartum at the time of ICF signing.
• Any condition that contraindicates the use of OCs.
• History of irregular menses, pregnancy, or adverse experiences while taking OCs.
• Use of hormonal contraceptives other than OCs (eg, transdermal patch, vaginal ring, intrauterine device) within 3 months, implanted contraceptives within 6 months, or injectable contraceptives for 12 months prior to screening.
• History of two or more drug allergies.
• History of allergy to Ortho Tri-Cyclen® or its generic equivalents.
• Presence of any clinically significant allergic disease (excluding non-active seasonal allergies like hay fever). 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).
• 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, or 5 half-lives of that investigational drug, if known (whichever is longer). 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.
• 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.
• Participant has used CYP3A inducers and/or inhibitors (including St. John's Wort) within 30 days preceding the first dose administration.
• Participant has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, or excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable. Other previous surgeries may be acceptable with concurrence of the Sponsor's Medical Monitor.

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Contraceptives, Oral; norgestimate, ethinyl estradiol drug combination

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Kofi Mensah, MD, PhD

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 22, 2021
• Study Start: September 30, 2020
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (3)