Healthy ParticipantsPhase 1DDINCT07226635
Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone
A Phase 1 study testing midazolam, clofutriben once daily for 16 days and 2 single oral doses of prednisolone in people with Healthy Participants, run by Sparrow Pharmaceuticals at 1 site in United States.
Trial summary
Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- midazolam, clofutriben once daily for 16 days and 2 single oral doses of prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 16 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.
Read the detailed 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.
- Conditions
- Healthy Participants
- Being tested
- midazolam, clofutriben once daily for 16 days, 2 single oral doses of prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Drug: 2 single oral doses of midazolam ,
clofutriben once daily for 16 daysDrug
clofutriben once daily for 16 days
2 single oral doses of prednisoloneDrug
2 single oral doses of prednisolone
| Study group | Role | What they receive |
|---|---|---|
| Experimental: midazolam | Experimental | Drug: 2 single oral doses of midazolam Receives: Drug: midazolam |
| 2 single oral doses of prednisolone | Experimental | 2 single oral doses of prednisolone Receives: Drug: 2 single oral doses of prednisolone |
| clofutriben once daily for 16 days | Experimental | clofutriben once daily for 16 days Receives: Drug: clofutriben once daily for 16 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours from dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start3 Oct 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sparrow Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226635
- Sponsor's protocol ID
- SPI-62-CL-1004
- Acronym
- DDI
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone
- ClinicalTrials.gov ID
- NCT07226635
- Acronym / sponsor ID
- DDI / SPI-62-CL-1004
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sparrow PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: midazolam | Experimental | Drug: midazolamDrug: 2 single oral doses of midazolam |
| 2 single oral doses of prednisolone | Experimental | Drug: 2 single oral doses of prednisolone2 single oral doses of prednisolone |
| clofutriben once daily for 16 days | Experimental | Drug: clofutriben once daily for 16 daysclofutriben once daily for 16 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- In the opinion of the investigator, the participant is not suitable for entry into the trial or has any contraindication to midazolam or prednisolone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolamDrug: 2 single oral doses of midazolam , | Drug | Experimental: midazolam |
| clofutriben once daily for 16 daysclofutriben once daily for 16 days | Drug | clofutriben once daily for 16 days |
| 2 single oral doses of prednisolone2 single oral doses of prednisolone | Drug | 2 single oral doses of prednisolone |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing midazolam, clofutriben once daily for 16 days and 2 single oral doses of prednisolone in people with Healthy Participants, run by Sparrow Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of midazolam. (time frame: 24 hours from dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.