Phase 1 Study of ANAVEX3-71 | NCT04442945

NCT04442945

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Anavex Australia Pty Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ANAVEX3-71	Drug	Active oral dose of ANAVEX3-71	ANAVEX3-71 Oral
Placebo

Outcomes Module

Primary Outcomes

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	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

Measure	Description	Time Frame
Effect on ECG, including the ECG QT Interval	To characterize the effect on ECG, including the ECG QT Interval for ANAVEX3-71	30 days

Eligibility Module

Eligibility Criteria

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.