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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04233437




Registration number
NCT04233437
Ethics application status
Date submitted
10/01/2020
Date registered
18/01/2020
Date last updated
3/09/2020

Titles & IDs
Public title
Drug-Drug Interaction Study of MLC1501 Using Cocktail of Drugs Acting as Sensitive Clinical Probes/Substrates of Cytochrome P450 Isoenzymes and Transporters in Healthy Subjects
Scientific title
Drug-Drug Interaction Study of MLC1501 Using Cocktail of Drugs Acting as Sensitive Clinical Probes/Substrates of Cytochrome P450 Isoenzymes and Transporters in Healthy Subjects
Secondary ID [1] 0 0
SAFE2019_01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MLC1501
Treatment: Drugs - CYP Cocktail
Treatment: Drugs - Transporter Cocktail

Experimental: CYP Cohort - MLC1501 & CYP cocktail drugs

Experimental: Transporter Cohort - MLC1501 & Transporter cocktail drugs


Treatment: Drugs: MLC1501
MLC1501 capsules (4 capcules (2000 mg) twice a day)

Treatment: Drugs: CYP Cocktail
Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg

Treatment: Drugs: Transporter Cocktail
Digoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in area under curve (AUC) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Timepoint [1] 0 0
Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Primary outcome [2] 0 0
Change in maximum concentration (Cmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Timepoint [2] 0 0
Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Primary outcome [3] 0 0
Change in time taken to reach maximum concentration (Tmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Timepoint [3] 0 0
Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Secondary outcome [1] 0 0
Ratio of geometric means (GMR) between cocktail alone and cocktail + MLC1501 for the AUC and Cmax of the corresponding probe
Timepoint [1] 0 0
Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.

Eligibility
Key inclusion criteria
1. Healthy subjects, male or female

2. 18 to 55 years old

3. Body mass index of 18 to <30 kg/m2

4. Able to understand the study requirements and provide written informed consent for
participation in the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any history of or presences of medical condition (such as hypertension, diabetes
mellitus, hyperlipidaemia, or any cardiac, neurological, pulmonary, gastrointestinal,
hepatic, hematologic, or renal disease).

2. Concurrent use of any medication to treat any medical condition

- CYP cohort: Within 72hr of the first dose of repaglinide or 5 half-lives of
dosing of any medication, whichever longer, and until the end of the study

- Transporter cohort: Within 72hr of first dose of Transporter cocktail or 5
half-lives of dosing of any medication, whichever longer, and until the end of
the study

3. Surgery within 4 weeks prior to Screening, as determined by the Investigator

4. History of stomach or intestinal surgery or resection that would potentially alter
absorption and/or excretion of orally administered drugs including cholecystectomy
(uncomplicated appendectomy and hernia repair will be allowed).

5. Use of tobacco- or nicotine-containing products within 72 hours prior to dosing.

6. Current substance or alcohol abuse/addiction

7. Women who are pregnant or breastfeeding.

8. Women who are of child-bearing potential unless they maintain abstinence during study
period or use barrier method of contraception and male partner using condom.
Systemically acting hormonal contraceptives are not allowed, however locally acting
hormonal contraceptives i.e. intrauterine device (IUD) (including Mirena) is allowed.
Menopausal/post-menopausal women without menstruation for 12 consecutive months or
surgically sterilized women may also be included. Intake of oral contraceptive pills
or hormone replacement therapy is not allowed.

9. Male subjects with female partner of child-bearing potential unless they maintain
abstinence during study period or use of barrier method of contraception with female
partner using any method of contraception.

10. Male subjects unless they are willing not to donate sperm 90 days from last study drug
administration.

11. Use or intend to use any medications or products known to alter drug absorption,
metabolism, or elimination processes, vitamin, minerals, herbal/traditional medicines
including St John's Wort. 20 days prior to the first dose, unless deemed acceptable by
the Investigator.

12. Caffeine-containing beverages, substance, alcohol, grapefruit juice/grapefruit
containing products, Seville oranges/ juice/, chamomile, liquorice, broccoli or
brussels sprouts within the 72hrs prior to dosing.

13. Any known hypersensitivity/allergic reaction/anaphylaxis to food, animal stings, drugs
inclusive of drugs used in CYP and transporter cocktail in the study /components of
MLC1501, or members of the Fabaceae/Leguminosae family (e.g. legume, pea, bean),
Polygalaceae family (e.g. milkwort, snakeroot), Apiaceae/ Umbelliferae family (e.g.
anise, caraway, carrot, celery, dill, parsley, parsnip), or Quillaja bark (soapbark).

14. Any abnormal physical examination findings or laboratory results (including serum
electrolytes such as sodium, potassium and chloride) or abnormal ECG findings (like
atrial fibrillation or flutter, supraventricular tachycardia, pre-excitation or wolff
Parkinson white. Etc) at screening that is considered to be clinically significant by
the study investigator.

15. Any medical condition which, in the study investigator's opinion, may jeopardize the
subject by his/her participation in this study, may hamper his/her ability to complete
procedures required in the study, or affect the validity of the study results.

16. Administration of an investigational drug (new chemical entity) or device trial within
90 days or 5 half-lives, whichever is longer, prior to the first dose, or concomitant
participation in an investigation study involving no drug administration.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
10/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/05/2020
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a single-centre phase I study to assess the Drug-Drug Interaction potential of
MLC1501 with a cocktail of drugs acting as sensitive clinical probe substrates of Cytochrome
P450 isoenzymes and Transporters in healthy subjects .

The study will have 2 cohorts, one for the CYP study and the other for the Transporters
study. Eligible subjects (n=24) will be assigned to one of the 2 cohorts in a 1:1 ratio.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04233437
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