Clinical trial NCT03411421: A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 40 days
measure: Part 1: ALS-033719 Plasma Concentrations
timeFrame: Predose up to Day 12
measure: Part 2: ALS-033719 Plasma Concentrations
timeFrame: Predose up to Day 5
measure: Part 1: ALS-033927 Plasma Concentrations
timeFrame: Predose up to Day 12
measure: Part 2: ALS-033927 Plasma Concentrations
timeFrame: Predose up to Day 5
Secondary outcomes:
measure: Part 1: ALS-033719 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions
timeFrame: Predose up to Day 12
measure: Part 1: ALS-033927 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions
timeFrame: Predose up to Day 12
measure: Part 1 and Part 2: Time-Matched Q-T Interval Corrected for Heart Rate Using Fridericia Method (QTcF)
timeFrame: Up to 40 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Hammersmith Medicines Research
name: Adeep Puri, MD
role: PRINCIPAL_INVESTIGATOR
References: