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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03411421
• Other study ID #: AL-794-806
• Secondary ID: AL-794-8062017-0
• Status: Terminated
• Phase: Phase 1
• Start date: March 3, 2018
• Est. completion date: April 27, 2018

Study information

• Verified date: June 2018
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AL-794
AL-794 will be administered as tablets orally on Day 1 to Day 5.
• Placebo
Matching placebo tablets will be administered.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Alios Biopharma Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 40 days
Primary	Part 1: ALS-033719 Plasma Concentrations	Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794.	Predose up to Day 12
Primary	Part 2: ALS-033719 Plasma Concentrations	Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794.	Predose up to Day 5
Primary	Part 1: ALS-033927 Plasma Concentrations	Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794.	Predose up to Day 12
Primary	Part 2: ALS-033927 Plasma Concentrations	Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794.	Predose up to Day 5
Secondary	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.	Predose up to Day 12
Secondary	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.	Predose up to Day 12
Secondary	Part 1 and Part 2: Time-Matched Q-T Interval Corrected for Heart Rate Using Fridericia Method (QTcF)	The QTcF will be measured by electrocardiogram (ECG).	Up to 40 days