A Phase 1 interventional study of midazolam and clofutriben once daily for 16 days in Healthy Participants, sponsored by Sparrow Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Sparrow Pharmaceuticals · Phase 1, Interventional, and Other
Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.
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.
Sparrow Pharmaceuticals is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 2 single oral doses of midazolam
Drug: midazolam
2 single oral doses of prednisolone
Drug: 2 single oral doses of prednisolone
clofutriben once daily for 16 days
Drug: clofutriben once daily for 16 days
Drug: 2 single oral doses of midazolam ,
clofutriben once daily for 16 days
2 single oral doses of prednisolone
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.
Time frame: 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.
Time frame: 24 hours from dose
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam
Sparrow Pharmaceuticals