A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Tersolisib in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Summary

The main purpose of this study is to measure how much tersolisib gets into the bloodstream and how long it takes the body to eliminate it in participants with kidney impairment compared to those with normal kidney function. The safety of tersolisib will also be evaluated. For each participant, the study will last about 7 weeks including a 14-night stay in the clinical research unit (CRU) and one follow-up telephone call.

Eligibility

Age range: 18–85 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Have a body mass index (BMI) within the range 19 to 42 kilograms per square meter (kg/m²), inclusive * Participants assigned male at birth (AMAB) who agree to follow contraception guidance or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP) Participants with Normal Renal Function: * Are healthy with normal renal function, defined as estimated glomerular filtration rate (eGFR) greater than or equal to 90 milliliters per minute (mL/min) at screening Participants with Renal Impairment: * Have moderate renal impairme…

Interventions

Drug
Tersolisib
Administered orally

Locations (2)

Omega Research Orlando
Altamonte Springs, Florida
Floridian Clinical Research
Miami Lakes, Florida

A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Tersolisib in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Summary

Eligibility

Interventions

Locations (2)

Compensation

Run this study?

Details

Conditions