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NCT Number: NCT06379958

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

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

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Key information

Conditions

Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Belfast, United Kingdom

Location status: Recruiting

Location contact

Nadine Abdullah

PRINCIPAL_INVESTIGATOR

Phase 1 Unit

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

  5. leramistat: Time of the maximum observed concentration - Tmax

    Time frame: 8.5 weeks

  6. leramistat:Elimination rate constant -Kel

    Time frame: 8.5 weeks

  7. leramistat: Half life - t½

    Time frame: 8.5 weeks

  8. leramistat: Plasma Clearance -CL/F

    Time frame: 8.5 weeks

  9. leramistat: Volume of distribution - Vz/F

    Time frame: 8.5 weeks

Secondary outcomes

  1. Incidence of adverse event.

    Time frame: 8.5 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

+44 (0)207 444 0066

Sponsors and collaborators

Lead sponsor

Modern Biosciences Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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