Healthy VolunteersPhase 1NCT04718636
A Study to Evaluate Effects of CC-99677 on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Participants
A Phase 1 study testing Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) and CC-99677 in people with Healthy Volunteers, run by Celgene at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of CC-99677 coadministration on the pharmacokinetics (PK) of an oral contraceptive (OC). Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) and CC-99677
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2020to 3 Aug 2021
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Participant donated blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.
- Participant has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual or other country-specific guideline within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
- Participant has a history of alcohol abuse or other country-specific guideline within 2 years before the first dose administration, or positive alcohol screen.
- Participant is known to have a history of hepatitis B and/or hepatitis C, or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Note: Participants who received hepatitis B vaccination and who test positive for hepatitis B surface antibody and negative for both hepatitis B surface antigen and hepatitis B core antibody remain eligible for study participation.
- Participant is older than 35 years of age and smokes any number of cigarettes per day or the equivalent in other tobacco products (self-reported).
- Participant is 35 years of age or younger and smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Participant has a history of incompletely treated Mycobacterium tuberculosis (TB) infection, as indicated by:
- Participant's medical records documenting incomplete treatment for Mycobacterium TB
- Participant's self-reported history of incomplete treatment for Mycobacterium TB
- Note: Participants with a history of TB who have undergone treatment accepted by the local health authorities (documented) may be eligible for study entry
- 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.
- 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.
- Participants with clinical symptoms or signs suggesting active, subacute, or unresolved chronic infection. All questions regarding this criterion should be discussed with the Sponsor.
- Participant has previously been exposed to CC-99677 (eg, in a prior clinical trial).
- Participant has a history of photosensitivity to medications.
- Participant is part of the study site staff personnel or a family member of the study site staff.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PPD Phase 1 Clinic
Austin, Texas, 78744
Hassman Research Institute
Marlton, New Jersey, 08053
Qps-Mra, Llc
Miami, Florida, 33143
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY ON THE EFFECTS OF CC-99677 ON THE PHARMACOKINETICS OF AN ORAL CONTRACEPTIVE IN HEALTHY FEMALE SUBJECTS
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
- Being tested
- Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent), CC-99677
- Keywords
- Healthy Female Volunteers, CC-99677, Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent)Drug
Daily
CC-99677Drug
Daily
| Study group | Role | What they receive |
|---|---|---|
| Administration of OC alone, then progress to OC in combination with CC-99677 | Experimental | Oral Contraceptive (OC) and CC-99677 will be administered daily Receives: Drug: Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent); Drug: CC-99677 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic - AUC0-τ
The area under the curve (AUC) for the defined interval between doses (TAU)
Measured: 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
Measured: Up to 36 hours post-dose
Pharmacokinetic - Cmax
Maximum observed plasma concentration occurring at Tmax
Measured: Up to 36 hours post-dose
Pharmacokinetic - Tmax
The time of maximum observed concentration sampled during a dosing interval
Measured: Up to 36 hours post-dose
Pharmacokinetic - t1/2
Terminal half-life
Measured: 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
Measured: 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
Measured: Up to 36 hours post-dose
Secondary outcomes (1)
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject 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 (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start30 Sep 2020
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kofi Mensah, MD, PhD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718636
- Sponsor's protocol ID
- CC-99677-CP-003
- Other IDs
- U1111-1258-2701
- Status last verified
- Oct 2021
- First submitted
- 6 Jan 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY ON THE EFFECTS OF CC-99677 ON THE PHARMACOKINETICS OF AN ORAL CONTRACEPTIVE IN HEALTHY FEMALE SUBJECTS
- ClinicalTrials.gov ID
- NCT04718636
- Acronym / sponsor ID
- CC-99677-CP-003
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Female Volunteers, CC-99677, Contraceptive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
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 effect of CC-99677 coadministration on the pharmacokinetics (PK) of an oral contraceptive (OC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of OC alone, then progress to OC in combination with CC-99677 | Experimental | Drug: Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent), Drug: CC-99677Oral Contraceptive (OC) and CC-99677 will be administered daily |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
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 |
|---|---|---|
| Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent)Daily | Drug | Administration of OC alone, then progress to OC in combination with CC-99677 |
| CC-99677Daily | Drug | Administration of OC alone, then progress to OC in combination with CC-99677 |
Primary outcome
Pharmacokinetic - AUC0-τ
Time frame: Up to 36 hours post-dose
The area under the curve (AUC) for the defined interval between doses (TAU)
Pharmacokinetic - AUC0-t
Time frame: Up to 36 hours post-dose
The area under the curve (AUC) from the time of dosing to the last measurable concentration
Pharmacokinetic - Cmax
Time frame: Up to 36 hours post-dose
Maximum observed plasma concentration occurring at Tmax
Pharmacokinetic - Tmax
Time frame: Up to 36 hours post-dose
The time of maximum observed concentration sampled during a dosing interval
Pharmacokinetic - t1/2
Time frame: Up to 36 hours post-dose
Terminal half-life
Pharmacokinetic - CL/F
Time frame: Up to 36 hours post-dose
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
Pharmacokinetic - Vz/F
Time frame: Up to 36 hours post-dose
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
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: 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/
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Healthy Participants
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.
Kofi Mensah, MD, PhD study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) and CC-99677 in people with Healthy Volunteers, run by Celgene at 3 sites in United States.
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 14 inclusion and 32 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic - AUC0-τ (time frame: Up to 36 hours post-dose). The study lists 7 primary outcomes in all. 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 28 Oct 2021.