Status:
TERMINATED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers
Lead Sponsor:
Alios Biopharma Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system \[CNS\] related events such as lightheadedness and dizziness), of multiple oral dose...
Eligibility Criteria
Inclusion
- Participant has provided written informed consent
- In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
- Participant is deemed healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
- Body mass index (BMI) 18 - 32 kilogram per meter square (kg/m\^2), inclusive. The minimum weight is 50 kilogram (kg). No more than 25 percent (%) of participants may be enrolled with a BMI greater than or equal to (\>=) 30 kg/m\^2
- Female participants must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test at screening and on Day -1 (admission)
Exclusion
- Female who is pregnant as confirmed by a positive beta-human chorionic gonadotropin (beta-hCG) laboratory test, or who was pregnant within 6 months prior to study start, or who is breast-feeding, or who is planning to become pregnant from signing of the informed consent form (ICF) until 90 days after the last dose of study drug
- Male whose female partner is pregnant or contemplating pregnancy from the date of screening until 90 days after their last dose of study drug
- Participant with one or more of the following laboratory abnormalities at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>= 1.2\*upper limit of normal (ULN); Alkaline phosphatase (ALP) \>= 1.2\*ULN; Total bilirubin \>= 1.2\*ULN; Clinically significant laboratory abnormalities or abnormalities which are deemed to interfere with the ability to interpret study data
- Creatinine clearance less than (\<) 90 milliliter per minute (mL/min) (using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation)
- Positive screening test for human immunodeficiency virus type 1 (HIV-1) or HIV-2 antibody, or for current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
Key Trial Info
Start Date :
March 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03411421
Start Date
March 3 2018
End Date
April 27 2018
Last Update
February 3 2025
Active Locations (1)
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1
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW