New cancer Drug's interactions under the microscope
NCT ID NCT07388511
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 study looked at how a new drug called elenestinib affects the way the body processes midazolam (a sedative) and a common birth control pill. Twenty healthy adult women took these drugs with and without elenestinib, and researchers measured drug levels in their blood. The goal was to see if elenestinib changes how these other drugs work, which is important for future safe use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- elenestinib
- What this could lead to
- If successful, this study will help doctors understand how elenestinib interacts with other drugs, leading to safer dosing guidelines.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. Results may not predict effects in people with the disease or with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Feb 2026
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Healthy, adult, female, 18-65 years of age, inclusive, at the screening visit that meet either of the following criteria: * Postmenopausal female, defined as amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status at the screening visit (note that participants may have had hysterectomy, bilateral salpingectomy, or bilateral tubal ligation). * Female status-post bilateral oophorectomy. * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 6 months prior to the first dosing. * BMI ≥ 18.0 and ≤ 35.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee. Key Exclusion Criteria: * History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. * History or presence of alcohol or drug abuse (except for the occasional use of cannabis products) within the past 1 years prior to the first dosing. * History or presence of cannabis use within the past 3 months prior to the first dosing. * History or presence of hypersensitivity or idiosyncratic reaction to elenestinib, midazolam, combined oral contraceptive (levonorgestrel/ethinyl estradiol), or related compounds. * Unable to refrain from or anticipates the use of: * Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. * Any drugs known to be moderate or strong inducers of CYP3A4 enzymes and/or P-gp beginning at least 28 days prior to first dosing. * Any drugs known to increase or decrease levels of SHBG, including any oral, topical, or intravaginal hormone-containing product, within 12 weeks prior to the first dosing. Other protocol-defined inclusion and exclusion criteria apply.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion, Inc
Tempe, Arizona, 85282, United States
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