Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000461897
Ethics application status
Approved
Date submitted
29/01/2021
Date registered
20/04/2021
Date last updated
3/05/2022
Date data sharing statement initially provided
20/04/2021
Date results information initially provided
3/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, open label study to evaluate the safety and pharmacokinetics of ML-004-ER under fed and fasted conditions in healthy adult volunteers
Scientific title
A Phase 1 Open Label Crossover Study to assess safety and bioavailability of ML-004-ER under Fasted and Fed Conditions in Adult Healthy Volunteers
Secondary ID [1] 303297 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of patients with autism spectrum disorder 320509 0
Condition category
Condition code
Neurological 318376 318376 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants in this study will receive 2 single doses of 24mg ML-004 extended-release oral tablets and 1 single dose of 20mg immediate-release oral tablets under fed (meal containing approximately 50% fat consumed 1 hour prior to dosing) or fasted (meal consumed 12 hours prior to dosing) conditions. The immediate-release dose will be administered on Day 1 and the extended-release doses will be administered on Day 2 (24 hours after the previous dose) and Day 4 (48 hours after the previous dose). The dosing schedule is the same for all participants.
Intervention code [1] 319600 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326350 0
To characterize the pharmacokinetic (PK) profile of ML-004-ER and immediate release tablets including bioavailability (BA) after single oral dose under fasted and fed conditions. PK profile determined through blood sampling to determine maximum plasma concentration (Cmax), time to Cmax, area under the curve (AUC) and elimination half-life.
Timepoint [1] 326350 0
Up to 48 hours after single oral daily dose (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 hours post-dose).
Secondary outcome [1] 391124 0
To evaluate the safety and tolerability of ML-004-ER single dose administered to healthy volunteers under fasted and fed conditions as assessed using the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Timepoint [1] 391124 0
Adverse events (AEs) and serious AEs (SAEs) will be recorded from start of treatment through to the end of the Follow-up Period (through Day 19).

Eligibility
Key inclusion criteria
1. Healthy adult male and female participants ages 18 to 45 years (inclusive).
2. Negative for drugs of abuse at Screening.
3. Body mass index (BMI) 21 to 32 kg/m2, inclusive.
4. Contraception:
a. If female, is either:
i. Not of childbearing potential, defined as postmenopausal (>/= 12 continuous months of amenorrhea with no other cause than menopause) or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, participants who practice sexual abstinence as part of their preferred and usual lifestyle, or participants in same-sex relationships.
ii. Of childbearing potential and participates in any activity associated with risk of pregnancy and is practicing at least 1 highly effective method of birth control (e.g., intrauterine device, oral or parenteral contraceptives, a vasectomized partner, abstinence from sexual intercourse). The Principal Investigator (PI) will discuss with the participant the option of practicing more than 1 of the above methods for the duration of the study through to 90 days post last dose.
b. If male and not surgically sterile, and partner is of childbearing potential, participant agrees to use male condom with spermicide (double-barrier method) for the duration of the study. Abstinence of sexual intercourse is an acceptable method of birth control if it is used continuously for the duration of the study.
5. Ability to participate, willingness to give written informed consent, and willingness to comply with the study restrictions.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have taken, with 4 weeks of Screening or Intake, any of the following:
• Selective Serotonin Reuptake Inhibitors (SSRIs)
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs).
• MAO-A inhibitors
• Another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication (example: dihydroergotamine or methysergide), including St John’s wort
2. Are taking cimetidine and are unable to discontinue use of cimetidine from Screening until the End of Study.
3. Significant current use of tobacco products, as judged by the Investigator.
4. Have a diagnosis or clinical history of cardiac, cerebrovascular or peripheral vascular disease, including Prinzmetal’s angina and Wolff-Parkinson-White syndrome
5. Screening or Intake systolic blood pressure >/=140mmHg (confirmed with repeat readings), or a clinical history of uncontrolled or severe hypertension.
6. Evidence of clinically significant ECG abnormalities at Screening or Baseline, in the clinical judgement of the Investigator.
7. Screening or Intake liver function tests that demonstrate an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal.
8. Diagnosed with, or clinical history of epilepsy or structural brain lesions reported at screening.
9. Diagnosed with, or clinical history of migraines, with or without aura reported at screening.
10. Known history of alcohol use disorder or other substance use disorder within 6 months prior to Screening.
11. Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening.
12. Pregnant or lactating female participants.
13. History of galactose intolerance (i.e., Lapp lactase deficiency or glucose-galactose malabsorption).
14. Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
15. Participated in the Phase 1 Pharmacokinetic Multiple Ascending Dose study (MAP-ZOL-HV-001).
16. Other medical or psychiatric condition which, in the opinion of the Investigator, would place the participant at increased risk of safety/tolerability issues and/or would preclude obtaining voluntary consent and/or would confound the interpretation of the primary outcome measures in the study.
17. Unwillingness or inability to comply with the study protocol, (including abstaining from all tobacco products during the dosing period and following a strict diet regime), for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2021
Actual
12/05/2021
Date of last participant enrolment
Anticipated
Actual
12/05/2021
Date of last data collection
Anticipated
Actual
1/07/2021
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18518 0
University of Sunshine Coast Health Clinics - Sippy Downs
Recruitment postcode(s) [1] 32858 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 307713 0
Commercial sector/Industry
Name [1] 307713 0
MapLight Therapeutics Inc
Country [1] 307713 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
MapLight Therapeutics Inc
Address
501 2nd Street
San Francisco CA 94107
Country
United States of America
Secondary sponsor category [1] 308413 0
Commercial sector/Industry
Name [1] 308413 0
Accelagen Pty Ltd
Address [1] 308413 0
Suite 1.02, 722 High Street
Kew East VIC 3102
Country [1] 308413 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307741 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 307741 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 307741 0
Australia
Date submitted for ethics approval [1] 307741 0
27/01/2021
Approval date [1] 307741 0
03/03/2021
Ethics approval number [1] 307741 0

Summary
Brief summary
This is a Phase 1 Open Label Crossover study of ML-004-ER, an extended release drug product (intended for use in the management of patients with autism spectrum disorder), in adult healthy volunteers that characterise the bioavailability and pharmacokinetic profile of single dose under fasted and fed conditions.

Each participants will receive a single oral dose of ML-004-ER prior to or following a designated meal, and the pharmacokinetic profile will be assessed for up to 24 hours to assess the impact food has on the rate and extent of absorption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108346 0
Dr Indika Leelasena
Address 108346 0
University of the Sunshine Coast
Level 1, 19-31 Dickson Road
Morayfield QLD 4506
Country 108346 0
Australia
Phone 108346 0
+61 481127484
Fax 108346 0
Email 108346 0
ileelasena@usc.edu.au
Contact person for public queries
Name 108347 0
Mr Greg Plunkett
Address 108347 0
Accelagen Pty Ltd
Suite 1.02, 722 High Street
Kew East VIC 3102
Country 108347 0
Australia
Phone 108347 0
+61 391142270
Fax 108347 0
Email 108347 0
info@accelagen.com.au
Contact person for scientific queries
Name 108348 0
Dr Jim Lillie
Address 108348 0
MapLight Therapeutics Inc
501 2nd Street
San Francisco CA 94107
Country 108348 0
United States of America
Phone 108348 0
+16177636511
Fax 108348 0
Email 108348 0
jlillie@maplightrx.com

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


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.