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Tyrosine Kinase Inhibitor

Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females aged 18 to 60 years, inclusive, at the time of signing the ICF
Ability to swallow and retain oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 32
Awards & highlights

Study Summary

This trial aims to investigate how the drug povorcitinib interacts with the birth control pill levonorgestrel/ethinyl estradiol in healthy adult women.

Who is the study for?
This trial is for healthy adult females who are interested in understanding how the drug Povorcitinib interacts with the oral contraceptive Levonorgestrel/Ethinyl Estradiol. Specific eligibility criteria details were not provided.Check my eligibility
What is being tested?
The study aims to investigate any interactions between a medication called Povorcitinib and a common birth control pill containing Levonorgestrel/Ethinyl Estradiol when taken by healthy women.See study design
What are the potential side effects?
Potential side effects were not detailed, but may include typical reactions to medications such as nausea, headaches, or other common drug-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 60.
Select...
I can swallow and keep down pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ethinyl estradiol (EE) concentration in plasma
Levonorgestrel (LNG) concentration in plasma
Secondary outcome measures
Additional LNG/EE PK parameters in plasma
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Povorcitinib concentration in plasma

Trial Design

1Treatment groups
Experimental Treatment
Group I: Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)Experimental Treatment2 Interventions
Povorcitinib and LNG/EE will be administered at the protocol defined doses.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Incyte CorporationLead Sponsor
366 Previous Clinical Trials
55,391 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
24 Previous Clinical Trials
5,168 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include individuals aged 40 and above in its recruitment process?

"Individuals aged above 18 and below 60 are eligible for participation in this clinical trial."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"According to details on clinicaltrials.gov, the current recruitment status of this particular study indicates that it is not actively enrolling participants. The trial's initial posting was on May 7th, 2024 and its latest update was made on April 18th, 2024. Despite this specific trial being closed for recruitment at present, there are a substantial number of 879 other trials currently open for patient enrollment."

Answered by AI

What are the potential risks associated with Povorcitinib in combination with levonorgestrel (LNG)/ethinyl estradiol (EE) for individuals?

"According to our assessment at Power, the safety rating for Povorcitinib combined with levonorgestrel (LNG)/ethinyl estradiol (EE) is categorized as 1. This classification reflects the early phase of this trial, indicating that available data on both safety and efficacy are currently limited."

Answered by AI
~16 spots leftby Jun 2024