Healthy FemalesPhase 1NCT03608241
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
A Phase 1 study testing PF-06651600 and Ethinyl estradiol (EE) and levonogestrel (LN) in people with Healthy Females, run by Pfizer at 2 sites in United States.
Trial summary
This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Females
- What is being tested?
- PF-06651600 and Ethinyl estradiol (EE) and levonogestrel (LN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2018to 23 Nov 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- Healthy female subjects of non childbearing potential
- Female subjects of non childbearing potential must meet at least 1 of the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and are not eligible for this study.
- Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Subjects with any of the following characteristics/conditions will not be included in the study:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of drug abuse with less than 6 months of abstinence prior to the baseline visit.
- History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
- Any medical reason which would contraindicate the administration of oral contraceptives (as per the label) or history of discontinued use of oral contraceptives due to medical reasons.
- Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
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- Subjects who have a malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Quotient Sciences
Coral Gables, Florida, 33134
Quotient Sciences-Miami, Inc.
Miami, Florida, 33126
About this study
Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE SUBJECTS
This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.
- Conditions
- Healthy Females
- Being tested
- PF-06651600, Ethinyl estradiol (EE) and levonogestrel (LN)
- Keywords
- female, post-menopausal, healthy, oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06651600Drug
200 mg by mouth (PO) Once daily (QD) for 11 days
Ethinyl estradiol (EE) and levonogestrel (LN)Drug
Also called Oral contraceptive
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period. Receives: Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonogestrel (LN) |
| Treatment Sequence 2 | Experimental | Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received. Receives: Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonogestrel (LN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: 0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: 0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Secondary outcomes (4)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Measured: Baseline (Day 0) up to 28 days after last dose of study drug
Number of Adverse Events by Severity
Measured: Baseline up to 28 days after last dose
Number of Participants With Categorical Vital Signs Data
Measured: Baseline through study completion, approximately 23 days.
Number of Participants With Change From Baseline in Laboratory Tests Results
Measured: Baseline through study completion, approximately 23 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start21 Sep 2018
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy FemalesStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608241
- Sponsor's protocol ID
- B7981018
- Status last verified
- Apr 2019
- First submitted
- 6 Jul 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE SUBJECTS
- ClinicalTrials.gov ID
- NCT03608241
- Acronym / sponsor ID
- B7981018
- Conditions
- Healthy Females
- Keywords
- female, post-menopausal, healthy, oral contraceptive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 31 Jul 2018 (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.
This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: PF-06651600, Drug: Ethinyl estradiol (EE) and levonogestrel (LN)Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period. |
| Treatment Sequence 2 | Experimental | Drug: PF-06651600, Drug: Ethinyl estradiol (EE) and levonogestrel (LN)Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- Healthy female subjects of non childbearing potential
- Female subjects of non childbearing potential must meet at least 1 of the following criteria:
- Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (9 listed)
- Subjects with any of the following characteristics/conditions will not be included in the study:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of drug abuse with less than 6 months of abstinence prior to the baseline visit.
- History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
- Any medical reason which would contraindicate the administration of oral contraceptives (as per the label) or history of discontinued use of oral contraceptives due to medical reasons.
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 |
|---|---|---|
| PF-06651600200 mg by mouth (PO) Once daily (QD) for 11 days | Drug | Treatment Sequence 2, Treatment sequence 1 |
| Ethinyl estradiol (EE) and levonogestrel (LN)Also: Oral contraceptiveSingle dose of Oral tablet containing 30 ug EE and 150 ug of LN | Drug | Treatment Sequence 2, Treatment sequence 1 |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
Time frame: 0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
Time frame: 0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
4 secondary outcomes
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 28 days after last dose of study drug
Number of Adverse Events by Severity
Time frame: Baseline up to 28 days after last dose
Number of Participants With Categorical Vital Signs Data
Time frame: Baseline through study completion, approximately 23 days.
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline through study completion, approximately 23 days.
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 9 Apr 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 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 PF-06651600 and Ethinyl estradiol (EE) and levonogestrel (LN) in people with Healthy Females, run by Pfizer at 2 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 7 inclusion and 9 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE (time frame: 0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose). The study lists 2 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 9 Apr 2019.