- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442945
Phase 1 Study of ANAVEX3-71
January 15, 2022 updated by: Anavex Life Sciences Corp.
A Double-blind, Randomized, Placebo-controlled, Phase 1 Safety and Tolerability, and Pharmacokinetics Study of ANAVEX3-71
A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
Study Overview
Detailed Description
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX Clinical Research Pty Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ANAVEX3-71 Oral
Up to four single ascending doses of ANAVEX3-71 administered orally
|
Active oral dose of ANAVEX3-71
|
Placebo Comparator: Placebo arm Oral
Placebo administered orally
|
Oral placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 30 days
|
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
Time Frame: 30 days
|
Serum concentration of ANAVEX3-71 at specified time points
|
30 days
|
Maximum plasma concentration (Cmax) for ANAVEX3-71
Time Frame: 30 days
|
Evaluate Cmax for serum concentration of ANAVEX3-71 at specified time points
|
30 days
|
Area under the curve concentration (AUC) for ANAVEX3-71
Time Frame: 30 days
|
Evaluate AUC for serum concentration of ANAVEX3-71 at specified time points
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on ECG, including the ECG QT Interval
Time Frame: 30 days
|
To characterize the effect on ECG, including the ECG QT Interval for ANAVEX3-71
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
October 30, 2021
Study Registration Dates
First Submitted
June 17, 2020
First Submitted That Met QC Criteria
June 19, 2020
First Posted (Actual)
June 23, 2020
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 15, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- ANAVEX3-71-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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