Healthy Female VolunteersPhase 1NCT04267250
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
A Phase 1 study testing PF-06700841 and Ethinyl estradiol (EE) and levonorgestrel (LN) in people with Healthy Female Volunteers, run by Pfizer at 2 sites in United States.
Trial summary
This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential. 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 Female Volunteers
- What is being tested?
- PF-06700841 and Ethinyl estradiol (EE) and levonorgestrel (LN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2020to 6 Nov 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
- Healthy females aged 18-60
- Not of childbearing potential
- Body mass index of 17.5-30.5 kg/m2
- Body weight > 50 kg
- Capable of giving signed informed consent
Who cannot join
- Evidence or history of clinically significant disease including irritable bowel disease; HIV; Hep B and Hep C; acute or chronic infection history; lymphoproliferative disorder; tuberculosis; hearing loss; sensitivity to heparin or heparin-induced thrombocytopenia
- Any condition affecting drug absorption
- Participants who have experienced major trauma or surgery in the 3 months prior to baseline
- Participants in imminent need for surgery
- Use of prescription or non-prescription drugs within 7 days or 5 half-lives prior to dosing
- Previous administration with an investigational drug within 30 days or 5 half-lives prior to dosing
Show all 20Show fewer
- A positive urine drug test
- Hypertension
- ECG anomalies
- Significant laboratory anomalies
- History of drug abuse with less than 6 months of abstinence prior to the baseline visit
- History of alcohol abuse within 6 months of screening
- History of nicotine use within 30 days of baseline visit
- Any contraindications to OC
- History of discontinued use of OC for medical reasons
- Febrile illness within 5 days prior to dosing
- Vaccination with live or attenuated virus or live viral components within 6 weeks prior to dosing
- History of major organ transplant
- History of severe allergic or anaphylactic reaction to kinase inhibitors
- have donated blood of 500mL or more within 60 days prior to dosing
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
About this study
Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06700841 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS
This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential.
Read the detailed description
This is a Phase 1, randomized, 2 way crossover, multiple-dose, open label study of the effect of multiple doses PF-06700841 on single dose combination oral contraceptive (OC) pharmacokinetics (PK) in healthy female participants aged 18-60.
The study consists of a screening phase (up to 28 days prior to Day 1); two treatment periods during which participants are resident in the Clinical Research Unit (CRU) and a final follow-up telephone contact, which will be conducted after 28-35 following administration of the last dose.
Participants will be randomized to 1 of 2 treatment sequences. A total of 18 healthy female participants (9 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods in a single fixed sequence. Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the Clinical Research Unit (CRU) the day prior to Day 1 dosing in Period 1 for both treatment sequences, and will report to the CRU the day prior to Day 1 dosing in Period 2 for Treatment Sequence 2. In Treatment Sequence 1, participants will remain in the CRU for up to 21 days and 20 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence 2, participants will remain in the CRU for up to 22 days and 20 nights. Participants in treatment sequence 2 will have an outpatient washout period of at least 10 days between Period 1 and Period 2. A single administration of OC in the form of 1 PORTIA or equivalent tablet will be administered in one of the two periods (reference treatment) and in the alternative treatment period, daily doses of 60 mg PF-06700841 will be administered for 13 days with a single dose of OC being administered on Day 10. PK (AUCinf, Cmax, AUClast, Tmax and t½) of OC will then be assessed at pre OC dose and over 96 hours, post OC dosing.
Safety assessments will be conducted at the CRU.
- Conditions
- Healthy Female Volunteers
- Being tested
- PF-06700841, Ethinyl estradiol (EE) and levonorgestrel (LN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06700841Drug
60 mg by mouth (PO) once daily (QD).
Ethinyl estradiol (EE) and levonorgestrel (LN)Drug
Oral tablet containing 30 mcg EE and 150 mcg LN.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | In sequence 1, period 1, participants will be dosed with a single administration of oral contraceptive (OC). Participants will continue directly into period 2 where they will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. Receives: Drug: PF-06700841; Drug: Ethinyl estradiol (EE) and levonorgestrel (LN) |
| Sequence 2 | Experimental | In sequence 2, period 1, participants will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. After a wash-out period of at least 10 days, participants will continue into period 2 where they will receive an additional single dose of OC. Receives: Drug: PF-06700841; Drug: Ethinyl estradiol (EE) and levonorgestrel (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), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2
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), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start24 Aug 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female VolunteersStudies 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
- 18 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
- NCT04267250
- Sponsor's protocol ID
- B7931018
- Other IDs
- Oral Contraceptive DDI
- Status last verified
- Nov 2020
- First submitted
- 10 Feb 2020
- Last updated
- 13 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. 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-06700841 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS
- ClinicalTrials.gov ID
- NCT04267250
- Acronym / sponsor ID
- B7931018
- Conditions
- Healthy Female Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 12 Feb 2020 (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 Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential.
Detailed description
This is a Phase 1, randomized, 2 way crossover, multiple-dose, open label study of the effect of multiple doses PF-06700841 on single dose combination oral contraceptive (OC) pharmacokinetics (PK) in healthy female participants aged 18-60.
The study consists of a screening phase (up to 28 days prior to Day 1); two treatment periods during which participants are resident in the Clinical Research Unit (CRU) and a final follow-up telephone contact, which will be conducted after 28-35 following administration of the last dose.
Participants will be randomized to 1 of 2 treatment sequences. A total of 18 healthy female participants (9 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods in a single fixed sequence. Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the Clinical Research Unit (CRU) the day prior to Day 1 dosing in Period 1 for both treatment sequences, and will report to the CRU the day prior to Day 1 dosing in Period 2 for Treatment Sequence 2. In Treatment Sequence 1, participants will remain in the CRU for up to 21 days and 20 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence 2, participants will remain in the CRU for up to 22 days and 20 nights. Participants in treatment sequence 2 will have an outpatient washout period of at least 10 days between Period 1 and Period 2. A single administration of OC in the form of 1 PORTIA or equivalent tablet will be administered in one of the two periods (reference treatment) and in the alternative treatment period, daily doses of 60 mg PF-06700841 will be administered for 13 days with a single dose of OC being administered on Day 10. PK (AUCinf, Cmax, AUClast, Tmax and t½) of OC will then be assessed at pre OC dose and over 96 hours, post OC dosing.
Safety assessments will be conducted at the CRU.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: PF-06700841, Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)In sequence 1, period 1, participants will be dosed with a single administration of oral contraceptive (OC). Participants will continue directly into period 2 where they will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. |
| Sequence 2 | Experimental | Drug: PF-06700841, Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)In sequence 2, period 1, participants will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. After a wash-out period of at least 10 days, participants will continue into period 2 where they will receive an additional single dose of OC. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy females aged 18-60
- Not of childbearing potential
- Body mass index of 17.5-30.5 kg/m2
- Body weight > 50 kg
- Capable of giving signed informed consent
Key exclusion criteria (20 listed)
- Evidence or history of clinically significant disease including irritable bowel disease; HIV; Hep B and Hep C; acute or chronic infection history; lymphoproliferative disorder; tuberculosis; hearing loss; sensitivity to heparin or heparin-induced thrombocytopenia
- Any condition affecting drug absorption
- Participants who have experienced major trauma or surgery in the 3 months prior to baseline
- Participants in imminent need for surgery
- Use of prescription or non-prescription drugs within 7 days or 5 half-lives prior to dosing
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-0670084160 mg by mouth (PO) once daily (QD). | Drug | Sequence 1, Sequence 2 |
| Ethinyl estradiol (EE) and levonorgestrel (LN)Oral tablet containing 30 mcg EE and 150 mcg LN. | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2
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), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2
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).
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 13 Nov 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-06700841 and Ethinyl estradiol (EE) and levonorgestrel (LN) in people with Healthy Female Volunteers, 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 5 inclusion and 20 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 13 Nov 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 Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2). 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 13 Nov 2020.