StrokePhase 1NCT04233437
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
A Phase 1 study testing MLC1501, CYP Cocktail and Transporter Cocktail in people with Stroke, run by Moleac Pte Ltd. at 1 site in Australia.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- MLC1501, CYP Cocktail and Transporter Cocktail
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Feb 2020to 16 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, male or female
- 18 to 55 years old
- Body mass index of 18 to <30 kg/m2
- Able to understand the study requirements and provide written informed consent for participation in the study.
Who cannot join
- 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).
- 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
- Surgery within 4 weeks prior to Screening, as determined by the Investigator
- 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).
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- Use of tobacco- or nicotine-containing products within 72 hours prior to dosing.
- Current substance or alcohol abuse/addiction
- Women who are pregnant or breastfeeding.
- 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.
- 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.
- Male subjects unless they are willing not to donate sperm 90 days from last study drug administration.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke
- Being tested
- MLC1501, CYP Cocktail, Transporter Cocktail
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC1501Drug
MLC1501 capsules (4 capcules (2000 mg) twice a day)
CYP CocktailDrug
Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg
Transporter CocktailDrug
Digoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg
| Study group | Role | What they receive |
|---|---|---|
| CYP Cohort | Experimental | MLC1501 \& CYP cocktail drugs Receives: Drug: MLC1501; Drug: CYP Cocktail |
| Transporter Cohort | Experimental | MLC1501 \& Transporter cocktail drugs Receives: Drug: MLC1501; Drug: Transporter Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area under curve (AUC) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Measured: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Change in maximum concentration (Cmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Measured: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Change in time taken to reach maximum concentration (Tmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Measured: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Secondary outcomes (1)
Ratio of geometric means (GMR) between cocktail alone and cocktail + MLC1501 for the AUC and Cmax of the corresponding probe
Measured: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 Feb 2020
- Primary completion16 May 2020
- Study completion16 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to either CYP or Transporter cohort in ratio of 1:1.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moleac Australia Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233437
- Sponsor's protocol ID
- SAFE2019_01
- Status last verified
- Sep 2020
- First submitted
- 10 Jan 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04233437
- Acronym / sponsor ID
- SAFE2019_01
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Moleac Australia Pty Ltd
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 16 May 2020 (actual)
- Study completion
- 16 May 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be assigned to either CYP or Transporter cohort in ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| CYP Cohort | Experimental | Drug: MLC1501, Drug: CYP CocktailMLC1501 \& CYP cocktail drugs |
| Transporter Cohort | Experimental | Drug: MLC1501, Drug: Transporter CocktailMLC1501 \& Transporter cocktail drugs |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects, male or female
- 18 to 55 years old
- Body mass index of 18 to <30 kg/m2
- Able to understand the study requirements and provide written informed consent for participation in the study.
Key exclusion criteria (18 listed)
- 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).
- Concurrent use of any medication to treat any medical condition
- Surgery within 4 weeks prior to Screening, as determined by the Investigator
- 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).
- Use of tobacco- or nicotine-containing products within 72 hours prior to dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MLC1501MLC1501 capsules (4 capcules (2000 mg) twice a day) | Drug | CYP Cohort, Transporter Cohort |
| CYP CocktailRepaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg | Drug | CYP Cohort |
| Transporter CocktailDigoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg | Drug | Transporter Cohort |
Primary outcome
Change in area under curve (AUC) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Change in maximum concentration (Cmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Change in time taken to reach maximum concentration (Tmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
1 secondary outcome
Ratio of geometric means (GMR) between cocktail alone and cocktail + MLC1501 for the AUC and Cmax of the corresponding probe
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MLC1501, CYP Cocktail and Transporter Cocktail in people with Stroke, run by Moleac Pte Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in area under curve (AUC) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration (time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.