Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib
ConditionHealthy Adult Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNuvation Bio Inc.
About this trial
This Phase 1 open-label trial aims to evaluate the effect of famotidine on the pharmacokinetics (PK), safety and tolerability of taletrectinib in healthy adult participants. To assess famotidine's impact on key PK parameters of taletrectinib and evaluate other PK parameters as well as safety endpoints.
The study design:
Part 1: Taletrectinib 600 mg administered under 2-hour fasting condition with three regimens: (Treatment A: Taletrectinib alone, Treatment B: Taletrectinib 2 h after single 40 mg famotidine. Treatment C: Taletrectinib dosed between two 20 mg famotidine doses).
Part 2: Taletrectinib 400 mg administered with standard low-fat meal, followed by either Treatment B or C of famotidine co-administration.
Eligibility criteria
Qualifiers
The participant must voluntarily sign an Informed Consent Form (ICF) prior to any study-related procedures.
Participants are able to communicate well with Investigators and complete the study in accordance with the protocol.
Between the ages of 18 and 55 years (inclusive) at the time of signing the ICF.
Healthy adult participants (healthy refers to the status of no clinically relevant abnormalities identified through medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory examinations).
Disqualifiers
Evidence or history of clinically significant hematology, kidney, endocrine, lung, gastrointestinal, cardiovascular, liver, mental, neurological, or allergic diseases (including drug allergies, but not including untreated, asymptomatic seasonal allergies at the time of dosing).
According to the Investigator's judgment, there are clinically significant abnormal laboratory results (hematology, serum chemistry, coagulation, and urinalysis).
Any active or unstable medical condition as judged by the Investigator.
The Investigator believes that the participant may be at increased risk of eye disease or have a history of eye disease, such as glaucoma, retinal shedding, glass turbidity, moth disease,etc.
Trial design
Treatments tested in this trial
- Taletrectinib
- Taletrectinib, Famotidine
- Taletrectinib, Famotidine
- Taletrectinib
- Taletrectinib, Famotidine
- Taletrectinib,Famotidine
Treatment groups
56 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov