Phase 1 Study of ANAVEX3-71

NCT04442945 | Completed Phase 1

• 1 other identifier: ANAVEX3-71-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Evaluation of safety and tolerability of ANAVEX3-71 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.

  30 days

• Pharmacokinetics (PK) of ANAVEX3-71

  Serum concentration of ANAVEX3-71 at specified time points

  30 days

• Maximum plasma concentration (Cmax) for ANAVEX3-71

  Evaluate Cmax for serum concentration of ANAVEX3-71 at specified time points

  30 days

• Area under the curve concentration (AUC) for ANAVEX3-71

  Evaluate AUC for serum concentration of ANAVEX3-71 at specified time points

  30 days

Secondary Outcomes (1)

• Effect on ECG, including the ECG QT Interval

  30 days

Study Arms (2)

ANAVEX3-71 Oral

EXPERIMENTAL

Up to four single ascending doses of ANAVEX3-71 administered orally

Drug: ANAVEX3-71

Placebo arm Oral

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

Interventions

ANAVEX3-71 DRUG

Active oral dose of ANAVEX3-71

ANAVEX3-71 Oral

Placebo DRUG

Oral placebo

Placebo arm Oral

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, male or female between 18 and 55 years of age, inclusive.
• Body mass index (BMI) between 19-28 kg/m2 and within a body weight of ≥ 60 kg and ≤ 120 kg.
• Female subjects must be of non-childbearing potential (defined as postmenopausal for at least 2 years or surgically sterile at least 6 months prior to dosing) or must be using adequate contraception.
• Subject is judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12-lead electrocardiogram (ECG).
• Non-smoker (no tobacco use within past 3 months).
• Subject is willing to comply with the study protocol, in the investigator's judgement.

You may not qualify if:

• Subject has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological (including myelosuppression and bleeding disorders) or immunological/autoimmune disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
• Positive test result on Hepatitis B surface antigen (HBsAg) or is Hepatitis C virus antibody (HCV-Ab) positive or positive HIV-1 and/or -2 serology.
• Subject has a history of chronic alcohol abuse within the last 2 years, or has a positive alcohol test or is known to have excessive alcohol intake.
• History of substance abuse, known drug addiction, or positive test for drugs of abuse.
• Subject has participated in another clinical trial of an investigational drug (or a medical device) within the last 3 months or is currently participating in another trial of an investigational drug (or a medical device).
• Female subject who is pregnant or lactating or planning a pregnancy.
• A history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study (psychosis is to be disqualified).
• Subject has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.

Sponsors & Collaborators

• Anavex Life Sciences Corp.: lead
• Anavex Australia Pty Ltd.: collaborator

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Study Design

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

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: July 3, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

AU (1)