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Plixorafenib Effects in Healthy Volunteers

Phase 1
Recruiting
Research Sponsored by Fore Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants with female partners of childbearing potential must be sterile or agree to use approved methods of contraception
Healthy male or non-pregnant, non-lactating female participants aged 18 to 55 years, inclusive, with a BMI of 18 kg/m2 or greater, but less than 30 kg/m2
Must not have
The participant has a diagnosis of chronic or acute liver disease
Male partners of females who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Awards & highlights

Summary

This trial aims to investigate how food and cobicistat impact the way plixerafenib is processed in the bodies of healthy volunteers between 18 and 55 years old. The study will

Who is the study for?
This trial is for healthy men and women aged between 18 and 55. Participants must meet all the study's requirements, which are not fully listed here. They should be able to take medication with or without food and have no health conditions that would interfere with the drug's absorption or their participation in the trial.Check my eligibility
What is being tested?
The study is testing how taking plixorafenib with cobicistat affects its levels in the body when taken with a meal (food) versus without food. It’s also looking at how safe it is to take these drugs together in a single dose among healthy volunteers.See study design
What are the potential side effects?
Since this information isn't provided, generally speaking, side effects could range from mild reactions like nausea or headaches to more serious ones depending on individual responses to plixorafenib and cobicistat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male willing to use contraception if my partner can have children.
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I am 18-55 years old, not pregnant or breastfeeding, with a healthy weight.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with liver disease.
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My partner is currently pregnant.
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I am not pregnant, breastfeeding, nor planning to become pregnant soon.
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I have donated blood in the last 3 months or have poor vein access.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from time 0 extrapolated to infinity (AUC0-inf).
Apparent oral clearance (CL/F).
Apparent volume of distribution (Vd/F).
+6 more
Secondary outcome measures
Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae).
Percent of dose excreted in urine in 48 hours calculated as 100*Ae/Dose.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment 3Experimental Treatment2 Interventions
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Group II: Treatment 2Experimental Treatment2 Interventions
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Group III: Treatment 1Experimental Treatment1 Intervention
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobicistat
2014
Completed Phase 2
~640

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Fore BiotherapeuticsLead Sponsor
6 Previous Clinical Trials
338 Total Patients Enrolled
Irina Kline, MDStudy ChairFore Biotherapeutics
1 Previous Clinical Trials
30 Total Patients Enrolled
~6 spots leftby Oct 2024