A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers

Launched by SYNEOS HEALTH · May 22, 2024

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• Participants must meet all of the following criteria to be included in the study:
• • 1. Male, \>=18 and less than or equal to (\<=) 65 years of age, with body mass index (BMI) greater than (\>) 18.5 and less than (\<) 32.0 kilogram per square meter (kg/m\^2) and body weight \>=50.0 kilogram (kg).
• • 2. Non-smoker (no use of tobacco or nicotine products, example, snuff, chewing tobacco, cigars, cigarettes, pipes, e-cigarettes \[vaping\] etc. within 3 months prior to screening).
• 3. Healthy as defined by:
• • 1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
• • 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• • 4. Sexually active non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
• • 5. Able to understand the study procedures and provide signed informed consent to participate in the study.
• Exclusion Criteria:
• Participants to whom any of the following applies will be excluded from the study:
• • 1. Any clinically significant abnormal finding at physical examination.
• • 2. Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) antibody, or Human immunodeficiency virus (HIV) antigen and antibody.
• • 3. Positive urine drug screen, cotinine test, or alcohol breath test.
• • 4. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
• • 5. Clinically significant Electrocardiograms (ECG) abnormalities or vital signs abnormalities (systolic blood pressure \[BP\] lower than 90 or over 140 millimeters of mercury \[mmHg\], diastolic BP lower than 50 or over 90 mmHg, heart rate \[HR\] less than 40 or over 100 beats per minute \[bpm\], or RR less than 10 or over 25 bpm) at screening.
• • 6. History of drug abuse within 1 year prior to screening or recreational use of marijuana within 1 month or other illegal drugs such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives within 3 months prior to screening.
• • 7. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units of alcohol per week (1 unit = 375 milliliter \[mL\] of beer 3.5 percent (%), or 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
• • 8. Use of medications within the timeframes specified in section.
• • 9. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
• • 10. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
• • 11. Optic nerve disease, cataracts, or a history of related conditions.
• • 12. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Trial Officials