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Itraconazole Effect on S-309309 in Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Shionogi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks postdose on days 1, 19
Awards & highlights

Study Summary

This trial looks at how taking itraconazole affects the body's absorption of S-309309.

Who is the study for?
This trial is for medically healthy adults with a BMI of 18.5 to 30.0 kg/m^2 who can follow the study's procedures and agree to use contraception according to local guidelines. People with significant past surgeries or current major health issues, severe drug allergies, or heart problems cannot participate.Check my eligibility
What is being tested?
The study aims to see how taking Itraconazole affects the body's handling of a new drug called S-309309. Participants will receive S-309309 alone and combined with Itraconazole so researchers can compare the differences in drug levels in the body.See study design
What are the potential side effects?
While specific side effects are not listed, common ones related to drugs like Itraconazole may include headache, stomach discomfort, dizziness, and rash. The new drug S-309309 might have unknown side effects that will be monitored during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks postdose on days 1, 19
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 weeks postdose on days 1, 19 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309
Area Under the Concentration-Time Curve Extrapolated From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) After Administration of S-309309
Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309
Secondary outcome measures
Number of Participants With Adverse Events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: S-309309Experimental Treatment2 Interventions
All participants will receive each of the following treatments: Days 1 and 19: S-309309 once daily (QD); in the fasted state) Day 15: Itraconazole twice daily (BID); in the fed state) Days 16 to 24: Itraconazole QD (in the fed state, except for Day 19 [co-administration with S-309309 in the fasted state])
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
2017
Completed Phase 2
~780
S309309
2023
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ShionogiLead Sponsor
116 Previous Clinical Trials
41,472 Total Patients Enrolled
Medical DirectorStudy DirectorShionogi
2,777 Previous Clinical Trials
8,063,850 Total Patients Enrolled

Frequently Asked Questions

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

Is there any possibility for me to partake in this medical experiment?

"The requirements to join this medical trial are obesity and an age range of 18-55 years old. A total of 14 willing participants is needed for the study's duration."

Answered by AI

Is participation in this research limited to those below a certain age?

"The age range of applicants who meet the criteria for this trial is from 18 to 55 years old. There are an additional 248 studies available targeting those younger than 18 and 1034 studies for individuals over 65."

Answered by AI

Has the U.S. Food and Drug Administration okayed S-309309 for public consumption?

"As this is an early Phase 1 trial, S-309309 was assigned a score of 1 for safety due to the limited evidence available on its efficacy and security."

Answered by AI

Is this medical trial still open for enrollment?

"According to clinicaltrials.gov, this investigation is no longer enrolling patients. Initially posted on November 15th 2023 and last updated October 24th, the trial unfortunately closed its recruitment process; however there are 1834 alternative studies currently searching for participants."

Answered by AI

Who else is applying?

What site did they apply to?
Fortrea Clinical Research Unit Inc.
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
2023. "Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106334.
~9 spots leftby Apr 2025
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