Clofutriben Interaction Study in Healthy Subjects

(DDI Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sparrow Pharmaceuticals

Must not be taking: Any medications

Disqualifiers: Poor health, Midazolam contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the new drug clofutriben interacts with other medications, such as midazolam and prednisolone, in healthy individuals. Researchers aim to observe how these drugs work together over a short period. Participants will take clofutriben daily for 16 days, along with a few doses of the other drugs. Individuals who are generally healthy, not on any medications, and have a body mass index between 18 and 35 may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

Yes, you must stop taking your current medications to participate in this trial, as it requires participants to be taking no medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found clofutriben to be generally safe and well-tolerated, showing promise in controlling blood sugar levels without major side effects. Major health organizations do not consider midazolam a cancer-causing agent, indicating its relative safety in certain situations. Prednisolone, commonly used for inflammation and allergies, may cause skin or eye irritation.

This trial is in Phase 1, marking one of the first times these treatments are tested in humans. The main goal is to assess their safety for people. Although safety information remains limited, early findings and past uses of these drugs offer some reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Clofutriben is unique because it offers a novel approach to treatment by being taken once daily for 16 days, potentially enhancing adherence and convenience compared to some existing therapies that require more frequent dosing. Researchers are excited about its distinct mechanism of action, which targets pathways differently than traditional options, offering hope for improved outcomes. Additionally, the use of midazolam and prednisolone in this study could reveal important insights into drug interactions, paving the way for more effective and safer combination therapies in the future.

What evidence suggests that this trial's treatments could be effective?

In this trial, participants will receive different treatments to study their interactions. Clofutriben, one potential treatment, has shown promise in previous studies by significantly lowering cortisol levels inside cells, which is important for conditions related to excess cortisol. Another study found that combining clofutriben with prednisolone was as effective as using a higher dose of prednisolone alone. Midazolam, another treatment option in this trial, is primarily used to study drug interactions in the body, especially with enzymes like CYP3A4, and its effectiveness for this purpose is well-documented. Prednisolone, a common anti-inflammatory, is also under study in this trial and has been effective in reducing symptoms in various conditions, including a noticeable reduction in psychotic symptoms compared to a placebo. These treatments are being studied for their potential benefits based on these findings. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18 to 75 with a body mass index between 18 to 35 kg/m2. Participants should be in good health, not taking any medications, and have no contraindications to midazolam or prednisolone.

Inclusion Criteria

Are considered by the investigator to be in good general health

I am between 18 and 75 years old.

I am not taking any medications.

Exclusion Criteria

My doctor thinks I shouldn't join the trial or I can't take midazolam or prednisolone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 single oral doses of midazolam, 2 single oral doses of prednisolone, and clofutriben once daily for 16 days

16 days

Daily visits for 16 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clofutriben
• Midazolam
• Prednisolone

Trial Overview The study tests how clofutriben affects the body's handling of two other drugs: midazolam and prednisolone. Each participant will take single oral doses of these drugs over a period of 16 days.

How Is the Trial Designed?

Group I: clofutriben once daily for 16 days Experimental Treatment 1 Intervention

clofutriben once daily for 16 days

Group II: Experimental: midazolam Experimental Treatment 1 Intervention

Drug: 2 single oral doses of midazolam

Group III: 2 single oral doses of prednisolone Experimental Treatment 1 Intervention

2 single oral doses of prednisolone

Who Is Running the Clinical Trial?

Sparrow Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

160+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226635

Pharmacokinetic Interaction Trial of Clofutriben With ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. sparrowpharma.com sparrowpharma.com/news/sparrowendo2-r5283-p222h

Sparrow Pharmaceuticals The new data suggest that clofutriben might step off that spectrum, achieving efficacy without dose titration and with a low risk of AI.

3. oxfordbrc.nihr.ac.uk oxfordbrc.nihr.ac.uk/collaboration-evaluates-new-drug-for-treatment-of-autonomous-cortisol-secretion/

Collaboration evaluates new drug for treatment of ... Its Chief Scientific Officer, David Katz, said: “Clofutriben substantially lowers intracellular cortisol, which can bind intracellular receptors ...

4. biospace.com biospace.com/press-releases/sparrow-pharmaceuticals-presented-new-data-on-clofutriben-and-prednisolone-for-polymyalgia-rheumatica-treatment-at-dgrh-kongress-2024

Sparrow Pharmaceuticals Presented New Data on ... A combination of prednisolone 20 mg with clofutriben showed similar efficacy as prednisolone 10 mg with placebo, based on analysis of ...

5. pharmacytimes.com pharmacytimes.com/view/clofutriben-receives-fda-orphan-drug-designation-to-treat-endogenous-cushing-syndrome

Clofutriben Receives FDA Orphan Drug Designation to ... The randomized, placebo-controlled RESCUE phase 3 trial assessed clofutriben among individuals with ACTH-dependent endogenous Cushing syndrome ...

6. medchemexpress.com medchemexpress.com/clofutriben.html?srsltid=AfmBOopHEUqYv7z4_qZTjK5nFgdCUcmrvRjzjC70QueznezKuEqS_GCJ

Clofutriben (ASP3662) | 11β-HSD Inhibitor SAFETY DATA SHEET (SDS). Request for HNMR Report. We have received your request and will respond to you as soon as possible. [e-mail]; 609-228 ...

7. sparrowpharma.com sparrowpharma.com/news/sparrowp2odd-r5283-p222h-f5j9r-xr7k9-9bxdk

Sparrow Pharmaceuticals The Phase 2 RESCUE trial of clofutriben, a potent and selective HSD-1 inhibitor, for the treatment of endogenous Cushing's syndrome is complete.

8. endocrine-abstracts.org endocrine-abstracts.org/ea/0110/ea0110rc4.3

Clofutriben inhibits 11ß-hydroxysteroid dehydrogenase ... Clofutriben decreased hepatic HSD-1 activity adequately to confer clinical benefit while maintaining safety and overall tolerability.

9. synapse.patsnap.com synapse.patsnap.com/drug/7459d645f01849b2af81b7c3830ec84c

Clofutriben - Drug Targets, Indications, Patents Clofutriben has been associated with improved glycemic control while generally safe and well tolerated in multiple clinical trials without requiring dose ...