Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001783213
Ethics application status
Approved
Date submitted
19/10/2018
Date registered
30/10/2018
Date last updated
12/11/2018
Date data sharing statement initially provided
30/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics (including Food Effect) of Single Ascending Doses of SAR441121 in healthy male subjects.
Scientific title
A Two-part, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Single Ascending Doses of SAR441121 Including a Pilot Food Evaluation (TDU15302) and its Antimalarial Activity against Plasmodium falciparum Blood Stage Infection (PDY15303) in Healthy Male Subjects.
Secondary ID [1] 296373 0
TDU15302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parasitic Diseases - Plasmodium falciparum
infection 310115 0
Condition category
Condition code
Infection 308865 308865 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be 5 groups each assigned to receive a different dose level of study drug or placebo. Choice of dose level(s) to be administered will be made based upon a review performed by the investigator and the sponsor representatives of the blinded safety, tolerability and pharmacokinetic data.

Arm 1 - Experimental: SAR441121 - a single dose starting at 5mg under fasting conditions (overnight fasting up to 4 hours post dose) according to an ascending dose design.
or
SAR441121 selected single dose in fed conditions. A standardized high fat breakfast of 800 kcal will be given to the participant 30 minutes prior to study drug intake.

Treatment: Drugs: SAR441121
Pharmaceutical form: Tablet
Route of administration: Oral
Duration: Single dose

The strategies used to monitor adherence to the study drug will be: administration under direct medical supervision, mouth inspection for checking the ingestion, appropriate record of the dosing information, counts of the number of tablets.
Intervention code [1] 312708 0
Treatment: Drugs
Comparator / control treatment
Arm 2 - Placebo Comparator - Matching placebo (microcellulose tablet) for SAR441121 single dose under fasting conditions.

Pharmaceutical form: Tablet
Route of administration: Oral
Duration: Single dose
Control group
Placebo

Outcomes
Primary outcome [1] 307835 0
To assess the tolerability and safety of ascending single oral doses of SAR441121 through , Number of participants with Adverse Events (AEs) by participant reporting and physician observation.
This study is a first in human study and there are no examples of treatment emergent adverse event (TEAE) that can be provided at this stage of drug development. From preclinical data, only monitoring of liver enzymes is proposed.
Timepoint [1] 307835 0
From 27 day screening period up to Day 28 post study drug administration,
Assessments are once during the screening period, the day prior to and day of study drug administration, daily up to 6 days post study drug administration, then weekly up to 28 days post study drug administration, or as reported by participant.
Secondary outcome [1] 353083 0
To assess the pharmacokinetic (PK) parameters of ascending single oral doses of SAR441121.
PK parameters are Cmax, tmax, AUClast, AUC, as assessed in plasma assay.
Timepoint [1] 353083 0
Day of study drug administration to Day 28 post study drug administration.
Daily from Day 1 to Day 5, then at Day 8, Day 14, Day 21, Day 28

Eligibility
Key inclusion criteria
Male subjects, between 18 and 49 years of age, inclusive.

Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.

Normal vital signs after 5 minutes resting in supine position.

Normal electrocardiogram parameters after 5 minutes resting in supine position.

Laboratory parameters within the normal range unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects.

Male subject, whose partners are of childbearing potential (including pregnant or lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing.

Male subject must agree not to donate sperm from the screening up to 3 months after the last dosing.
Minimum age
18 Years
Maximum age
49 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.

Presence or history of drug hypersensitivity, or allergic disease diagnosed by an allergist/immunologist and/or treated by a physician for allergy or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion, or subjects with a documented food allergy requiring specific medical management

History or presence of alcohol abuse (alcohol consumption of more than 40g per day) or drug habituation, or any previous usage of an illicit substance.

Tobacco use of more than 5 cigarettes or equivalent per day, and unable to stop smoking for the duration of the clinical unit confinement.

Any medication (including St John’s Wort) within 14 days before consenting or within 5 times the elimination half-life or pharmacodynamic half-life of the medication except occasional intakes of ibuprofen at doses up to 1.2g/day or paracetamol at doses up to 2g/day.

Participation in any investigational product study within the 12 weeks (counted from the last dose taken) prior to Investigational Medicinal Product (IMP) administration.

Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 3 months before inclusion.

Any consumption of grapefruit and Sevilles oranges, etc or their juices within 5 days prior to Investigational Medicinal Product (IMP) administration.

For the food effect cohort, vegetarian subjects or subjects with lactose intolerance must be excluded.

History of serious psychiatric condition that may affect participation in the study or preclude compliance with the protocol, including but not limited to past or present psychoses, disorders requiring lithium, a history of attempted or planned suicide, more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/10/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
24/06/2019
Actual
Sample size
Target
62
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12210 0
Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
Recruitment postcode(s) [1] 24388 0
4007 - Herston

Funding & Sponsors
Funding source category [1] 300977 0
Commercial sector/Industry
Name [1] 300977 0
sanofi-aventis R&D
Country [1] 300977 0
France
Primary sponsor type
Commercial sector/Industry
Name
sanofi-aventis australia ptd ltd
Address
Building D, 12-24 Talavera Rd,
Macquarie Park, NSW, 2113
Country
Australia
Secondary sponsor category [1] 300561 0
None
Name [1] 300561 0
Address [1] 300561 0
Country [1] 300561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301739 0
QIMR Berghofer Medical Research Institute Human Research Ethics Committee
Ethics committee address [1] 301739 0
300 Herston Rd,
Herston, QLD, 4006
Ethics committee country [1] 301739 0
Australia
Date submitted for ethics approval [1] 301739 0
19/06/2018
Approval date [1] 301739 0
06/09/2018
Ethics approval number [1] 301739 0

Summary
Brief summary
SAR441121 is an experimental treatment. This means that it is not an approved treatment for Malaria in Australia by the Regulatory Authority (Therapeutic Goods Administration - TGA) or any other international Regulatory Authority.
The purpose of this study is to establish the safety, tolerability (how easily it is to tolerate) and pharmacokinetics (what the body does to the study drug, such as absorption, distribution and excretion) of SAR441121 in healthy male volunteers, This study also aims to investigate the effect that food may have in the safety, tolerability and pharmacokinetics of the study drug.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87950 0
Prof James McCarthy
Address 87950 0
QIMR Berghofer Medical Research Institute
300 Herston Rd,
Herston, QLD 4006
Country 87950 0
Australia
Phone 87950 0
+61 7 3845 3796
Fax 87950 0
Email 87950 0
[email protected]
Contact person for public queries
Name 87951 0
Saba Zia
Address 87951 0
Q-Pharm Pty Ltd
300 Herston Rd,
Herston, QLD 4006
Country 87951 0
Australia
Phone 87951 0
+61 499 089 169
Fax 87951 0
Email 87951 0
[email protected]
Contact person for scientific queries
Name 87952 0
Emilie Rossignol
Address 87952 0
QIMR Berghofer Medical Research Institute
300 Herston Rd,
Herston, QLD 4006
Country 87952 0
Australia
Phone 87952 0
+61 7 3845 3856
Fax 87952 0
Email 87952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregated results will be presented


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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