Phase
Condition
Healthy Volunteers
Treatment
Placebo
FTX-101
Clinical Study ID
Ages 18-59 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Willingness to comply with all study procedures and availability for the duration ofthe 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 evidenceof clinically significant findings on the physical examination (including vitalsigns) and/or ECG.
Exclusion
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 hypersensitivityreactions (like angioedema) to any drugs
Presence or history of significant gastrointestinal, liver or kidney disease, orsurgery 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, intakeof excessive alcohol, acute or chronic)
Any history of substance or alcohol use disorder within the past 2 years and/orcurrent maintenance therapy (within the past 2 years) for treatment of substance usedisorder
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 aninvestigator 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 treatmentadministration
Positive screening results to HIV Ag/Ab combo, hepatitis B surface Ag or hepatitis Cvirus tests
Intake of an investigational product (IP) in the 28 days prior to the first studytreatment 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 ordonation of over 500 mL of blood in the 56 days prior to the first study treatmentadministration
Study Design
Study Description
Connect with a study center
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas 66212
United StatesActive - Recruiting
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