Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids

NCT04267250

Last updated date
Study Location
Quotient Sciences Screening Office
Coral Gables, Florida, 33134, United States
Contact
1-800-718-1021

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Female Volunteers
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


- 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

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Healthy Female VolunteersEffect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids NCT04267250
  1. Coral Gables, Florida
  2. Miami, Florida
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
Official Title  ICMJE 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
Brief 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.
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 a total of 20 days and 19 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence 2, participants will remain in the CRU for a total of 21 days and 19 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Female Volunteers
Intervention  ICMJE
  • Drug: PF-06700841
    60 mg by mouth (PO) once daily (QD).
  • Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)
    Oral tablet containing 30 mcg EE and 150 mcg LN.
Study Arms  ICMJE
  • Experimental: Sequence 1
    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.
    Interventions:
    • Drug: PF-06700841
    • Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)
  • Experimental: Sequence 2
    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.
    Interventions:
    • Drug: PF-06700841
    • Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2020)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 29, 2020
Estimated Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04267250
Other Study ID Numbers  ICMJE B7931018
Oral Contraceptive DDI ( Other Identifier: Alias Study Number )
Oral Contraceptive Interaction ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP