multiple myeloma multiple myeloma
Conditions
Interventions
Part 1
During Part 1 of the study, no study compound will be given.
Part 2
Subjects will receive a single oral dose with 150 mg nirogacestat (3 tablets of
50 mg each) on Day 1.
Part 3
The dose and
Sponsors
SpringWorks Therapeutics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 2. Participant understands the study procedures, is willing to comply with all study requirements and restrictions and agrees to participate in the study by providing written informed consent as described in Appendix 1, prior to any study-related procedures being performed. 3. Participant is a male between 18 and 55 years of age (inclusive) at the time of informed consent. 4. Participant has a body mass index (BMI) >= 18 kg/m2 and 50 kg. 5. Participant is considered to be medically healthy, as determined by a responsible and experienced investigator, based on a clinical evaluation (including medical history, physical examination, clinical laboratory tests, vital sign measurements and a 12-lead ECG) performed as directed in the SoA (Section 1.3), Section 1.2.1; and the results of clinical chemistry, and hematology carried out at Screening and Day -1 (Parts 1 and 4) or Day -2 (Parts 2 and 3).
Exclusion criteria
Exclusion criteria: 1. Participant has a history or presence of oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, ocular, endocrine, immunologic, dermatologic, musculoskeletal, neurological, psychiatric or other disease or condition or the laboratory test abnormality that in the investigator*s judgment poses a significant risk to the safety of the participant or the achievement of study objectives. 2. Participant has a medical history or abnormal findings at Screening or Day -1 (Parts 1 and 4) or Day -2 (Parts 2 and 3) that the investigator judges may put at risk achieving the objectives of the study or protecting the safety of the participant. 3. Participant has an acute illness with symptom or treatment that has started or persisted within 14 days prior to study treatment administration unless mild in severity and enrollment is approved by both Investigator and Sponsor*s medical monitor. 4. Participant has clinically significant infections (e.g., HBV, HCV, HIV) within 90 days prior to Day 1, as judged by the investigator, or evidence of any infection with the past 14 days prior to Day 1. 5. Participant has blood pressure (BP) that is greater than or equal to 140 mm Hg systolic or 90 mm Hg diastolic following at least 5 minutes of rest at Screening or Day -1 (Parts 1 and 4) or Day -2 (Parts 2 and 3). Additionally, BP that is less than 90 mm Hg systolic or 45 mmHg diastolic following at least 5 minutes of rest at Screening or Day -1 (Parts 1 and 4) or Day -2 (Parts 2 and 3).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To evaluate the pharmacodynamics (PD) of nirogacestat on BCMA • To evaluate the serum nirogacestat exposure-response relationship to membrane-bound BCMA (mbBCMA) and soluble BCMA (sBCMA) kinetics after single dose administration of nirogacestat | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the pharmacokinetics of serum nirogacestat after single and multiple dose administration of nirogacestat • To evaluate the safety and tolerability of single and multiple dose nirogacestat in healthy male participants | — |
Countries
Netherlands
Outcome results
None listed