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

Moleac

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Drug: Transporter Cocktail; Drug: MLC1501; Drug: CYP Cocktail

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04233437

SAFE2019_01

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

CYP Cohort

Experimental group

Description:

MLC1501 \& CYP cocktail drugs

Treatment:

Drug: CYP Cocktail

Drug: MLC1501

Transporter Cohort

Experimental group

Description:

MLC1501 \& Transporter cocktail drugs

Treatment:

Drug: Transporter Cocktail

Drug: MLC1501