HealthyPhase 1NCT04134715

A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants

A Phase 1 study testing PF-06826647 and Oral Contraceptive (OC) in people with Healthy, run by Pfizer at 2 sites 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

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-06826647 and Oral Contraceptive (OC)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: 23 Oct 2019to 9 Jan 2020
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 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy female participants of non-childbearing potential must be 18 to 60 years of age, inclusive
2. Female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, laboratory tests, and 12 lead ECG
3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
4. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

Who cannot join

1. 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).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
3. History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives).
4. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
5. Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
6. Participants who use tobacco or nicotine containing products.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Quotient Sciences Screening Office
Coral Gables, Florida, 33134
Quotient Sciences-Miami
Miami, Florida, 33126

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-06826647 ON THE PHARMACOKINETICS OF ORAL CONTRACEPTIVE STEROIDS AND TO ESTIMATE THE EFFECT OF ORAL CONTRACEPTIVE STEROIDS ON PHARMACOKINETICS OF PF-06826647 IN HEALTHY FEMALE PARTICIPANTS

This is a Phase 1, fixed sequence, multiple dose, open label study of the effect of PF-06826647 on oral contraceptive (OC) pharmacokinetics (PK) and vice versa in healthy female participants. A total of approximately 15 healthy female participants will be enrolled and dosed to achieve at least 12 participants completing the study.

Conditions: Healthy
Being tested: PF-06826647, Oral Contraceptive (OC)
Keywords: Oral contraceptive, Drug-Drug Interaction (DDI), PF-06826647

What participants receive

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

PF-06826647Drug
100 mg tablet
Oral Contraceptive (OC)Drug
OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet

Study groups in NCT04134715
Study group	Role	What they receive
PF-06826647 alone then OC alone then OC+PF-06826647	Experimental	In Period 1 (Period 1 is 2 days), participants will receive a single dose of PF-06826647 600 mg on Day 1. Period 2 (Period 2 is 14 days) will immediately follow Period 1 without any washout. In Period 2, the participants will receive OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet, orally starting from Period 2 Day 1 until Period 3-Day 16 (Period 3 is 17 Days). Period 3 will immediately follow Period 2 with no washout. In Period 3 on Day 1, the participants will receive a single dose of PF-06826647 600 mg. On Day 2 in Period 3, PF-06826647 will not be dosed. From Day 3, the participants will receive PF-06826647 600 mg QD for 14 days followed by OC in the form of 1 PORTIA (EE and LN) or equivalent tablet. Receives: Drug: PF-06826647; Drug: Oral Contraceptive (OC)

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 Zero To End of Dosing Interval (AUGtau) of Ethinyl Estradiol (EE)
Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.
Measured: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)
Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Levonorgestrel (LN)
Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.
Measured: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06826647
AUCinf is calculated by AUClast + (Clast*/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)
Maximum Plasma Concentration (Cmax) of PF-06826647
Cmax will be observed directly from data.
Measured: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)

Secondary outcomes (6)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
Measured: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), and pulse rate.
Measured: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology
Hematology evaluation includes: hemoglobin, hematocrit, red blood cell (RBC) count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, white blood cell count (WBC), neutrophils, eosinophils, monocytes, basophils, lymphocytes and reticulocytes.
Measured: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry
Clinical chemistry evaluation includes: blood urea nitrogen, creatinine, fasting glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, urate, albumin, protein, creatinine kinase
Measured: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis
Urinalysis evaluation includes: qual urine glucose, qual protein, qual blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, urine leukocytes.
Measured: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG
Measured: Baseline (Period 1 Day 1), Day 1 (Period 1 and Period 2) up to Day 17 (Period 3)

Timeline

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

23 Oct 20199 Jan 2020

First posted22 Oct 2019
Study start23 Oct 2019
Primary completion9 Jan 2020
Study completion9 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Other
Intervention model: Sequential
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04134715
Sponsor's protocol ID: C2501005
Status last verified: Feb 2020
First submitted: 4 Sep 2019
Last updated: 5 Feb 2020
Results posted: 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.

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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-06826647 ON THE PHARMACOKINETICS OF ORAL CONTRACEPTIVE STEROIDS AND TO ESTIMATE THE EFFECT OF ORAL CONTRACEPTIVE STEROIDS ON PHARMACOKINETICS OF PF-06826647 IN HEALTHY FEMALE PARTICIPANTS
ClinicalTrials.gov ID: NCT04134715
Acronym / sponsor ID: C2501005
Conditions: Healthy
Keywords: Oral contraceptive, Drug-Drug Interaction (DDI), PF-06826647
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 23 Oct 2019 (actual)
Primary completion: 9 Jan 2020 (actual)
Study completion: 9 Jan 2020 (actual)
First posted: 22 Oct 2019 (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.

Study design

Primary purpose: Other
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-06826647 alone then OC alone then OC+PF-06826647	Experimental	Drug: PF-06826647, Drug: Oral Contraceptive (OC)In Period 1 (Period 1 is 2 days), participants will receive a single dose of PF-06826647 600 mg on Day 1. Period 2 (Period 2 is 14 days) will immediately follow Period 1 without any washout. In Period 2, the participants will receive OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet, orally starting from Period 2 Day 1 until Period 3-Day 16 (Period 3 is 17 Days). Period 3 will immediately follow Period 2 with no washout. In Period 3 on Day 1, the participants will receive a single dose of PF-06826647 600 mg. On Day 2 in Period 3, PF-06826647 will not be dosed. From Day 3, the participants will receive PF-06826647 600 mg QD for 14 days followed by OC in the form of 1 PORTIA (EE and LN) or equivalent tablet.

Who may qualify

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

Key inclusion criteria (4 listed)

1. Healthy female participants of non-childbearing potential must be 18 to 60 years of age, inclusive
2. Female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, laboratory tests, and 12 lead ECG
3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
4. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

Key exclusion criteria (6 listed)

1. 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).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
3. History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives).
4. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
5. 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-06826647100 mg tablet	Drug	PF-06826647 alone then OC alone then OC+PF-06826647
Oral Contraceptive (OC)OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet	Drug	PF-06826647 alone then OC alone then OC+PF-06826647

Primary outcome

Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Ethinyl Estradiol (EE)
Time frame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)
Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.
Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Levonorgestrel (LN)
Time frame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)
Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06826647
Time frame: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)
AUCinf is calculated by AUClast + (Clast*/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Maximum Plasma Concentration (Cmax) of PF-06826647
Time frame: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)
Cmax will be observed directly from data.

6 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology
Time frame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry
Time frame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis
Time frame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline (Period 1 Day 1), Day 1 (Period 1 and Period 2) up to Day 17 (Period 3)

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 5 Feb 2020.
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-06826647 and Oral Contraceptive (OC) in people with Healthy, 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 4 inclusion and 6 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 5 Feb 2020. 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 Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Ethinyl Estradiol (EE) (time frame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)). 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 NCT04134715.

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 5 Feb 2020.