A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers

Phase 1TerminatedNCT03411421

Alios Biopharma Inc.27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

AL-794DRUG

AL-794 will be administered as tablets orally on Day 1 to Day 5.

PlaceboDRUG

Matching placebo tablets will be administered.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hammersmith Medicines Research

London, United Kingdom

Outcomes

Primary Outcomes

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

An AE is any untoward medical occurrence in a participant who received study drug or placebo without regard to possibility of causal relationship.

Time frame: Up to 40 days

Part 1: ALS-033719 Plasma Concentrations

Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794.

Time frame: Predose up to Day 12

Part 2: ALS-033719 Plasma Concentrations

Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794.

Time frame: Predose up to Day 5

Part 1: ALS-033927 Plasma Concentrations

Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794.

Time frame: Predose up to Day 12

Part 2: ALS-033927 Plasma Concentrations

Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794.

Time frame: Predose up to Day 5

Secondary Outcomes

Part 1: ALS-033719 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions

Plasma concentration assessment will be done for ALS-033719, after repeated oral doses of AL-794, in healthy women under fasted and fed conditions.

Time frame: Predose up to Day 12

Part 1: ALS-033927 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions

Plasma concentration assessment will be done for ALS-033927, after repeated oral doses of AL-794, in healthy women under fasted and fed conditions.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.