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Completed

NCT Number: NCT07226635

Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone

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

Completed

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Key information

Conditions

Healthy Participants

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Research Unit

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

midazolam

Drug

Drug: 2 single oral doses of midazolam ,

clofutriben once daily for 16 days

Drug

clofutriben once daily for 16 days

2 single oral doses of prednisolone

Drug

2 single oral doses of prednisolone

Primary outcomes

  1. Cmax of midazolam.

    Time frame: 24 hours from dose

    It will be concluded that there is no relevant interaction of clofutriben on midazolam if the 90% CIs for the Cmax ratios (midazolam + clofutriben)/midazolam alone) are contained within the [80%, 125%] interval.

  2. AUC0-t of midazolam

    Time frame: 24 hours from dose

    : It will be concluded that there is no relevant interaction of clofutriben on midazolam if the 90% CIs for the AUC0-t (midazolam + clofutriben)/midazolam alone) are contained within the [80%, 125%] interval.

Sponsors and collaborators

Lead sponsor

Sparrow Pharmaceuticals

Industry

Registry information

Acronym: DDI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 10, 2025
Registry last updated
Jul 8, 2026

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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