Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone

NCT07226635 | Completed Phase 1 FDA Drug

• 1 other identifier: SPI-62-CL-1004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Cmax of midazolam.

  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.

  24 hours from dose

• AUC0-t of midazolam

  : 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.

  24 hours from dose

Study Arms (3)

Experimental: midazolam

EXPERIMENTAL

Drug: 2 single oral doses of midazolam

Drug: midazolam

2 single oral doses of prednisolone

EXPERIMENTAL

2 single oral doses of prednisolone

Drug: 2 single oral doses of prednisolone

clofutriben once daily for 16 days

EXPERIMENTAL

clofutriben once daily for 16 days

Drug: clofutriben once daily for 16 days

Interventions

midazolam DRUG

Drug: 2 single oral doses of midazolam ,

Experimental: midazolam

clofutriben once daily for 16 days DRUG

clofutriben once daily for 16 days

clofutriben once daily for 16 days

2 single oral doses of prednisolone DRUG

2 single oral doses of prednisolone

2 single oral doses of prednisolone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (1)

PPD Austin Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: October 3, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-11

Locations

US (1)