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

NCT03411421 | Terminated Phase 1

• 2 other identifiers: AL-794-8062017-004193-34
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

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

  Predose up to Day 12

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

  Predose up to Day 12

• Part 1 and Part 2: Time-Matched Q-T Interval Corrected for Heart Rate Using Fridericia Method (QTcF)

  Up to 40 days

Study Arms (2)

Part 1 (AL-794 or Placebo)

EXPERIMENTAL

Participants will receive AL-794 or placebo in 2:1 ratio in Cohorts 1 to 3. AL-794 will be administered at a 100 milligram (mg) loading dose (LD) on the morning of Day 1, followed by a 50 mg maintenance dose (MD) on the evening of Day 1 and twice-daily (BID) on Day 2 through Day 5. The duration of dosing may be extended (maximum duration 10 days), at the discretion of the Sponsor and Principal Investigator (PI).

Drug: AL-794; Drug: Placebo

Part 2 (AL-794 or Placebo)

EXPERIMENTAL

Participants will receive AL-794 or placebo in 2:1 ratio. AL-794 will be administered as 100 mg LD on the morning of Day 1, followed by a 50 mg MD on the evening of Day 1 and BID on Day 2 through Day 5. The duration of dosing may be extended (maximum duration 10 days). Based on the results of Part 1, the duration of dosing may be modified.

Drug: AL-794; Drug: Placebo

Interventions

AL-794 DRUG

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

Part 1 (AL-794 or Placebo); Part 2 (AL-794 or Placebo)

Placebo DRUG

Matching placebo tablets will be administered.

Part 1 (AL-794 or Placebo); Part 2 (AL-794 or Placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alios Biopharma Inc.: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

sfericase

Study Officials

• Adeep Puri, MD

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 26, 2018
• Study Start: March 3, 2018
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

GB (1)