Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone (DDI)

Sparrow Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: midazolam; Drug: clofutriben once daily for 16 days; Drug: 2 single oral doses of prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226635

SPI-62-CL-1004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Experimental: midazolam

Experimental group

Description:

Drug: 2 single oral doses of midazolam

Treatment:

Drug: midazolam

2 single oral doses of prednisolone

Experimental group

Description:

2 single oral doses of prednisolone

Treatment:

Drug: 2 single oral doses of prednisolone

clofutriben once daily for 16 days

Experimental group

Description:

clofutriben once daily for 16 days

Treatment:

Drug: clofutriben once daily for 16 days