HealthyPhase 1NCT05064332

A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)

A Phase 1 study testing PF-06650833 and Ethinyl estradiol (EE) and levonogestrel (LN) in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects. Read more about this study

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-06650833 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: 10 participants
Where: 1 siteUnited States
Study dates: 8 Oct 2021to 16 Dec 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 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
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 will be eligible with adequate contraceptive usage.
Body mass index (BMI) of 17.5 to 30.5 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 alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
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
Benign ethnic (cyclic) neutropenia.

Trial locations and contacts

1 site in 1 country.

United States1 site

Qps-Mra, Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A PHASE 1, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06650833 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS

This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.

Conditions: Healthy
Being tested: PF-06650833, Ethinyl estradiol (EE) and levonogestrel (LN)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06650833Drug
400 mg by mouth (PO) Once daily (QD) for 11 days
Ethinyl estradiol (EE) and levonogestrel (LN)Drug
Also called Oral contraceptive (OC)
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Study groups in NCT05064332
Study group	Role	What they receive
OC only	Experimental	Subjects will receive a single dose of an oral contraceptive during the first period of the study Receives: Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
PF-06650833 + OC	Experimental	Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10. Receives: Drug: PF-06650833; 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 Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for EE was determined using linear/Log trapezoidal method.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for LN was determined using linear/Log trapezoidal method.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol
Cmax was defined as maximum plasma concentration. Cmax for EE was observed directly from data.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Maximum Plasma Concentration for Levonorgestrel
Cmas was defined as maximum plasma concentration. Cmax for LN was observed directly from data.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2

Secondary outcomes (4)

Number of Participants With Treatment Emergent Treatment-Related Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the first dose up to 35 days after the last dose of study intervention
Number of Participants With Treatment Emergent Adverse Events by Severity
An AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. AEs are classified according to the severity in 3 categories. a) mild - AEs does not interfere with participant's usual function; b) moderate - AEs interferes to some extent with participant's usual function; c) severe - AEs interferes significantly with participant's usual function. Only those categories in which at least 1 participant had data were reported.
Measured: From the first dose up to 35 days after the last dose of study intervention
Number of Participants With Categorical Vital Signs Data of Potential Clinical Concern
Systolic blood pressure (BP), diastolic BP and supine pulse rate measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: Systolic BP min. <90 mmHg; Systolic BP max. decrease ≥30 or max. increase ≥30; Diastolic BP min. <50 mmHg; Diastolic BP max. decrease ≥20 or max. increase ≥20; Supine pulse rate min. <40 bpm or max. >120 bpm.
Measured: Day 1 for Period 1 and Day 1, Day 10, Day 12 for Period 2
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
Hematology (hemoglobin, hematocrit, erythrocytes [Ery.], Ery.mean corpuscular volume, Ery.mean corpuscular hemoglobin, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); clinical chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase); and urinalysis (pH, glucose, ketones, protein, hemoglobin, urobilinogen, bilirubin, nitrite, leukocyte esterase, Ery., leukocytes, epithelial cells, casts and bacteria) tests were assessed. Only those categories, in which at least 1 participant had data were reported.
Measured: Day 10, Day 12 for Period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202116 Dec 2021

First posted1 Oct 2021
Study start8 Oct 2021
Primary completion16 Dec 2021
Study completion16 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05064332
Sponsor's protocol ID: B7921026
Status last verified: Nov 2022
First submitted: 22 Sep 2021
Last updated: 2 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06650833 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS
ClinicalTrials.gov ID: NCT05064332
Acronym / sponsor ID: B7921026
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 8 Oct 2021 (actual)
Primary completion: 16 Dec 2021 (actual)
Study completion: 16 Dec 2021 (actual)
First posted: 1 Oct 2021 (actual)
Results: Posted 2 Oct 2023

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, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OC only	Experimental	Drug: Ethinyl estradiol (EE) and levonogestrel (LN)Subjects will receive a single dose of an oral contraceptive during the first period of the study
PF-06650833 + OC	Experimental	Drug: PF-06650833, Drug: Ethinyl estradiol (EE) and levonogestrel (LN)Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Healthy female subjects
Female subjects of non childbearing potential must meet at least 1 of the following criteria:
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and will be eligible with adequate contraceptive usage.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (7 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 alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

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-06650833400 mg by mouth (PO) Once daily (QD) for 11 days	Drug	PF-06650833 + OC
Ethinyl estradiol (EE) and levonogestrel (LN)Also: Oral contraceptive (OC)Single dose of Oral tablet containing 30 ug EE and 150 ug of LN	Drug	OC only, PF-06650833 + OC

Primary outcome

Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for EE was determined using linear/Log trapezoidal method.
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for LN was determined using linear/Log trapezoidal method.
Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Cmax was defined as maximum plasma concentration. Cmax for EE was observed directly from data.
Maximum Plasma Concentration for Levonorgestrel
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Cmas was defined as maximum plasma concentration. Cmax for LN was observed directly from data.

4 secondary outcomes

Number of Participants With Treatment Emergent Treatment-Related Adverse Events
Time frame: From the first dose up to 35 days after the last dose of study intervention
Number of Participants With Treatment Emergent Adverse Events by Severity
Time frame: From the first dose up to 35 days after the last dose of study intervention
Number of Participants With Categorical Vital Signs Data of Potential Clinical Concern
Time frame: Day 1 for Period 1 and Day 1, Day 10, Day 12 for Period 2
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
Time frame: Day 10, Day 12 for Period 2

Results and safety

Results posted to the registry on 2 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Contraceptive (OC) Then PF-06650833+ OC	10	10

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2. Geometric mean (Geometric Coefficient of Variation). Unit: picogram*hour per milliliter (pg*hr/mL)

Measure	Period 1: Oral Contraceptive n = 10	Period 2: PF-06650833 + Oral Contraceptive n = 10
Value	812.3 (25)	823.9 (26)

Period 1: Oral Contraceptive vs Period 2: PF-06650833 + Oral Contraceptive: Ratio of Adjusted Geometric Means: 101.43 (90% CI 93.01 to 110.61)

Population analysed: The PK parameter analysis population was defined as all participants that received at least 1 dose of study intervention and had at least 1 of the PK parameters of primary interest reported in at least 1 period.

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2. Geometric mean (Geometric Coefficient of Variation). Unit: pg*hr/mL

Measure	Period 1: Oral Contraceptive n = 10	Period 2: PF-06650833 + Oral Contraceptive n = 10
Value	31510 (39)	34190 (41)

Period 1: Oral Contraceptive vs Period 2: PF-06650833 + Oral Contraceptive: Ratio of Adjusted Geometric Means: 108.51 (90% CI 98.85 to 119.11)

Primary outcome: Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2. Geometric mean (Geometric Coefficient of Variation). Unit: picogram per milliliter (pg/mL)

Measure	Period 1: Oral Contraceptive n = 10	Period 2: PF-06650833 + Oral Contraceptive n = 10
Value	84.00 (38)	79.86 (26)

Period 1: Oral Contraceptive vs Period 2: PF-06650833 + Oral Contraceptive: Ratio of Adjusted Geometric Means: 95.07 (90% CI 84.44 to 107.04)

Primary outcome: Maximum Plasma Concentration for Levonorgestrel

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Period 1: Oral Contraceptive n = 10	Period 2: PF-06650833 + Oral Contraceptive n = 10
Value	3468 (56)	4092 (53)

Period 1: Oral Contraceptive vs Period 2: PF-06650833 + Oral Contraceptive: Ratio of Adjusted Geometric Means: 117.99 (90% CI 101.82 to 136.73)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose up to 35 days after the last dose of study intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1: Oral Contraceptive	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Period 2: PF-06650833	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Period 2: PF-06650833 + Oral Contraceptive	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

1 site 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-06650833 and Ethinyl estradiol (EE) and levonogestrel (LN) in people with Healthy, run by Pfizer at 1 site 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 8 inclusion and 7 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 2 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol (time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064332.

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 2 Oct 2023.