PharmacokineticsPhase 1NCT06379958
Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects
A Phase 1 study testing leramistat 40mg, Itraconazole 200 mg and Phenytoin 100 Mg Oral Capsule in people with Pharmacokinetics, run by Modern Biosciences Ltd at 1 site in United Kingdom.
Trial summary
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- leramistat 40mg, Itraconazole 200 mg and Phenytoin 100 Mg Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2024to 30 Sep 2024
- 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
Principal Inclusion Criteria:
Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.
Principal Exclusion Criteria:
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Celerion
Belfast
Phase 1 Unit
Nadine Abdullah
About this study
Official title: A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.
- Conditions
- Pharmacokinetics
- Being tested
- leramistat 40mg, Itraconazole 200 mg, Phenytoin 100 Mg Oral Capsule, Simvastatin 40mg, Upadacitinib 15 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leramistat 40mgDrug
Oral capsule
Itraconazole 200 mgDrug
Oral capsule
Phenytoin 100 Mg Oral CapsuleDrug
Oral capsule
Simvastatin 40mgDrug
Oral capsule
Upadacitinib 15 MGDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Itraconazole 200mg | Active comparator | Not described Receives: Drug: leramistat 40mg; Drug: Itraconazole 200 mg |
| Part 2: Phenytoin 100mg | Active comparator | Not described Receives: Drug: leramistat 40mg; Drug: Phenytoin 100 Mg Oral Capsule |
| Part 3: Simvastatin 40mg | Active comparator | Not described Receives: Drug: leramistat 40mg; Drug: Simvastatin 40mg |
| Part 4: Upadacitinib 15 mg | Active comparator | Not described Receives: Drug: leramistat 40mg; Drug: Upadacitinib 15 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
leramistat: Area under the curve - AUC0-t
Measured: 8.5 Weeks
leramistat: Area under the curve - AUC0-24h
Measured: 8.5 Weeks
leramistat: Area under the curve - AUC0-inf
Measured: 8.5 weeks
leramistat: Maximum observed concentration - Cmax
Measured: 8.5 weeks
leramistat: Time of the maximum observed concentration - Tmax
Measured: 8.5 weeks
leramistat:Elimination rate constant -Kel
Measured: 8.5 weeks
leramistat: Half life - t½
Measured: 8.5 weeks
leramistat: Plasma Clearance -CL/F
Measured: 8.5 weeks
leramistat: Volume of distribution - Vz/F
Measured: 8.5 weeks
Secondary outcomes (1)
Incidence of adverse event.
Measured: 8.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start8 Apr 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modern Biosciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379958
- Sponsor's protocol ID
- IST-05
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06379958
- Acronym / sponsor ID
- IST-05
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Modern Biosciences LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Apr 2024 (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.
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Itraconazole 200mg | Active comparator | Drug: leramistat 40mg, Drug: Itraconazole 200 mg |
| Part 2: Phenytoin 100mg | Active comparator | Drug: leramistat 40mg, Drug: Phenytoin 100 Mg Oral Capsule |
| Part 3: Simvastatin 40mg | Active comparator | Drug: leramistat 40mg, Drug: Simvastatin 40mg |
| Part 4: Upadacitinib 15 mg | Active comparator | Drug: leramistat 40mg, Drug: Upadacitinib 15 MG |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| leramistat 40mgOral capsule | Drug | Part 1: Itraconazole 200mg, Part 2: Phenytoin 100mg, Part 3: Simvastatin 40mg, Part 4: Upadacitinib 15 mg |
| Itraconazole 200 mgOral capsule | Drug | Part 1: Itraconazole 200mg |
| Phenytoin 100 Mg Oral CapsuleOral capsule | Drug | Part 2: Phenytoin 100mg |
| Simvastatin 40mgOral capsule | Drug | Part 3: Simvastatin 40mg |
| Upadacitinib 15 MGOral Capsule | Drug | Part 4: Upadacitinib 15 mg |
Primary outcome
leramistat: Area under the curve - AUC0-t
Time frame: 8.5 Weeks
leramistat: Area under the curve - AUC0-24h
Time frame: 8.5 Weeks
leramistat: Area under the curve - AUC0-inf
Time frame: 8.5 weeks
leramistat: Maximum observed concentration - Cmax
Time frame: 8.5 weeks
leramistat: Time of the maximum observed concentration - Tmax
Time frame: 8.5 weeks
leramistat:Elimination rate constant -Kel
Time frame: 8.5 weeks
leramistat: Half life - t½
Time frame: 8.5 weeks
leramistat: Plasma Clearance -CL/F
Time frame: 8.5 weeks
leramistat: Volume of distribution - Vz/F
Time frame: 8.5 weeks
1 secondary outcome
Incidence of adverse event.
Time frame: 8.5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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 leramistat 40mg, Itraconazole 200 mg and Phenytoin 100 Mg Oral Capsule in people with Pharmacokinetics, run by Modern Biosciences Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Team (+44 (0)207 444 0066, ist05@istesso.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leramistat: Area under the curve - AUC0-t (time frame: 8.5 Weeks). The study lists 9 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 9 Aug 2024.