SAD and MAD Study of FTX-101 in Healthy Male Subjects

Launched by FIND THERAPEUTICS · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called FTX-101 to understand how it behaves in the human body. It is a Phase 1 study, which means it is the first time this medication is being tested in healthy male volunteers. The trial has two parts: the first part will look at how a single dose of the medication affects participants, and the second part will examine the effects of multiple doses over time. The trial is currently recruiting healthy men aged 18 to 59 who meet specific health criteria, such as having a normal weight and no significant medical conditions.

Participants in this study can expect to attend a single center where they will receive either the medication or a placebo (a substance with no active ingredients) and undergo various health assessments. It’s important for potential participants to know that they will need to follow the study procedures closely and that certain health issues, such as heart conditions or substance use disorders, may exclude them from participating. This study aims to gather important safety and effectiveness information about FTX-101, which could help in developing new treatments in the future.

Gender

MALE

Eligibility criteria

• Key Inclusion Criteria:
• • Willingness to comply with all study procedures and availability for the duration of the study
• • Healthy adult male
• • Aged at least 18 years but not older than 59 years
• • Body mass index (BMI) within 18.5 kg/m\^2 to 32.0 kg/m\^2, inclusively
• • Non- or ex-smoker
• • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG.
• Key Exclusion Criteria:
• • Supine or semi-supine pulse rate less than 45 beats per minute (bpm) or more than 100 bpm
• • Supine or semi-supine blood pressure below 90/50 mmHg
• • Supine or semi-supine blood pressure higher than 150/95 mmHg
• • History of significant hypersensitivity to FTX-101 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• • Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
• • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• • Showing suicidal tendency from 6 months prior to screening
• * Presence of out-of-range cardiac intervals at screening defined as:
• • PR \< 110 msec, PR \> 200 msec
• • QRS \< 60 msec, QRS \>110 msec)
• • QT Interval Corrected for Heart Rate using Fridericia's Correction Formula (QTcF): • \> 450 msec
• • History of additional risk factors for torsade's de pointes
• • Use of concomitant medications that prolong the QT/ corrected QT (QTc) interval
• • Current use (in the last 6 months) of alcohol (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• • Any history of substance or alcohol use disorder within the past 2 years and/or current maintenance therapy (within the past 2 years) for treatment of substance use disorder
• • Use of any prescription drugs in the 28 days or 5 half-lives, whichever is longer, prior to the first study treatment administration, that in the opinion of an investigator would put into question the status of the participant as healthy
• • Use of St. John's wort in the 28 days prior to the first study treatment administration
• • Positive screening results to HIV Ag/Ab combo, hepatitis B surface Ag or hepatitis C virus tests
• • Intake of an investigational product (IP) in the 28 days prior to the first study treatment administration or within 5 times the elimination half-life of the IP, whichever is longer
• • Donation of plasma in the 7 days prior to the first study treatment administration
• • Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study treatment administration