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NCT07259330Phase 1ACTIVE NOT RECRUITING

To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants

Study Summary

This study will evaluate the effects of nirogacestat 100 mg twice daily (BID) on the pharmacokinetics (PK) of a cytochrome P450 (CYP) cocktail.

Conditions
Healthy
Interventions / Drugs
NirogacestatNirogacestat and Cocktail of CYP Specific Probe Substrates
View on ClinicalTrials.gov ↗
Sponsor
SWTX
SpringWorks Therapeutics
Rare Oncology
D40/100
Study Details
Enrollment20 participants
Primary Completion—
Lead SponsorSpringWorks Therapeutics, Inc.
Data Retrieved2026-04-11 04:28:29.597224+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 20 participants
Sponsor Catalyst Profile

SpringWorks Therapeutics (SWTX) is the sponsoring company for this trial. BiotechSign currently grades this company D (40/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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