MedDataX Logo

Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone

NCT ID: NCT07226635

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-03

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Approximately 16 healthy male and female participants will be enrolled at a single center in the US. Each participant will receive 2 single oral doses of midazolam , 2 single oral doses of prednisolone, and clofutriben once daily for 16 days. On each day that midazolam is administered, blood samples for midazolam analysis in plasma will be collected for 24 hours. On each day that prednisolone is administered, blood samples for prednisolone, prednisone, and 6β-hydroxyprednisolone analyses in plasma will be collected for 24 hours.

Blood samples for clofutriben and metabolite (AS2570469) analyses in plasma will be collected for 24 hours after the first dose and during 2 intervals at steady state. Blood samples for cortisol and cortisone analyses will be collected for 24 hours after administration of prednisolone, clofutriben, and both trial interventions together, and prior to dosing of either trial intervention. Urine will be collected for analysis of clofutriben, prednisolone, and metabolites. Feces will be collected for analysis of clofutriben and metabolites. Safety and tolerability will be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: midazolam

Drug: 2 single oral doses of midazolam

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

Drug: 2 single oral doses of midazolam ,

2 single oral doses of prednisolone

2 single oral doses of prednisolone

Group Type EXPERIMENTAL

2 single oral doses of prednisolone

Intervention Type DRUG

2 single oral doses of prednisolone

clofutriben once daily for 16 days

clofutriben once daily for 16 days

Group Type EXPERIMENTAL

clofutriben once daily for 16 days

Intervention Type DRUG

clofutriben once daily for 16 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

midazolam

Drug: 2 single oral doses of midazolam ,

Intervention Type DRUG

clofutriben once daily for 16 days

clofutriben once daily for 16 days

Intervention Type DRUG

2 single oral doses of prednisolone

2 single oral doses of prednisolone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female participants aged 18 to 75 years of age,
* Body mass index of 18 to 35 kg/m2,
* Taking no medications,
* Are considered by the investigator to be in good general health.

Exclusion Criteria

* In the opinion of the investigator, the participant is not suitable for entry into the trial or has any contraindication to midazolam or prednisolone.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sparrow Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PPD Austin Research Unit

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPI-62-CL-1004

Identifier Type: -

Identifier Source: org_study_id