Health TrialsbyHealthPanel

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

ConditionPharmacokinetics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorModern Biosciences Ltd

About this trial

A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • leramistat 40mg

    Drug

    Oral capsule

  • Itraconazole 200 mg

    Drug

    Oral capsule

  • Phenytoin 100 Mg Oral Capsule

    Drug

    Oral capsule

  • Simvastatin 40mg

    Drug

    Oral capsule

  • Upadacitinib 15 MG

    Drug

    Oral Capsule

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Part 1: Itraconazole 200mgActive comparator 2 interventions
Group B: Part 2: Phenytoin 100mgActive comparator 2 interventions
Group C: Part 3: Simvastatin 40mgActive comparator 2 interventions
Group D: Part 4: Upadacitinib 15 mgActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

leramistat: Area under the curve - AUC0-t

Time frame
8.5 Weeks
2

leramistat: Area under the curve - AUC0-24h

Time frame
8.5 Weeks
3

leramistat: Area under the curve - AUC0-inf

Time frame
8.5 weeks
4

leramistat: Maximum observed concentration - Cmax

Time frame
8.5 weeks

Secondary outcomes

1

Incidence of adverse event.

Time frame
8.5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Modern Biosciences Ltd

Lead sponsor

Source ClinicalTrials.gov
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