Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04442945




Registration number
NCT04442945
Ethics application status
Date submitted
17/06/2020
Date registered
23/06/2020
Date last updated
19/01/2022

Titles & IDs
Public title
Phase 1 Study of ANAVEX3-71
Scientific title
A Double-blind, Randomized, Placebo-controlled, Phase 1 Safety and Tolerability, and Pharmacokinetics Study of ANAVEX3-71
Secondary ID [1] 0 0
ANAVEX3-71-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ANAVEX3-71
Treatment: Drugs - Placebo

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

Placebo Comparator: Placebo arm Oral - Placebo administered orally


Treatment: Drugs: ANAVEX3-71
Active oral dose of ANAVEX3-71

Treatment: Drugs: Placebo
Oral placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Pharmacokinetics (PK) of ANAVEX3-71
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Maximum plasma concentration (Cmax) for ANAVEX3-71
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
Area under the curve concentration (AUC) for ANAVEX3-71
Timepoint [4] 0 0
30 days
Secondary outcome [1] 0 0
Effect on ECG, including the ECG QT Interval
Timepoint [1] 0 0
30 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2021
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Anavex Life Sciences Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Anavex Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety,
tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
Trial website
https://clinicaltrials.gov/ct2/show/NCT04442945
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04442945