The aims of the study are: * to assess the safety profile of danavorexton when it is administered with anesthetics. * to learn what effect danavorexton has on anesthetized adults. On Day 1, participants will receive a single intravenous (IV) infusion of danavorexton or a placebo after participants have been anesthetized for about 40 minutes. Clinic doctors will arrange a follow-up visit by phone or video on Day 7.
The drug being tested in this study is called danavorexton or TAK-925. Danavorexton is being tested to evaluate safety, tolerability, PK, and pharmacodynamics (PD) in healthy participants. The study will enroll approximately 28 participants. This study consists of 4 cohorts: Cohorts A1, A2, A3 and P (healthy participants aged 18 to 55 years). In each of the 4 cohorts, participants will be randomly assigned (by chance) to receive danavorexton or danavorexton placebo-matching -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Cohort A1: Danavorexton Low Dose * Cohort A2: Danavorexton Middle Dose * Cohort A3: Danavorexton High Dose * Cohort P: Danavorexton TBD Additional optional cohorts may be added to the study based on the outcomes from the mandatory cohorts described above. This trial will be conducted in the United States. The overall time to participate in this study is 37 days including screening period, residential period, and safety follow up period. A follow-up visit by phone or video will be conducted on Day 7.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
28
Danavorexton intravenous infusion.
Danavorexton placebo-matching intravenous infusion.
Propofol intravenous bolus.
Endeavor Clinical Trials
San Antonio, Texas, United States
Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)
Time frame: Up to Day 7
Ceoi: Observed Plasma Concentration at the end of Infusion for Danavorexton
Time frame: Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Danavorexton
Time frame: Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Danavorexton
Time frame: Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
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Sevoflurane inhalation.
Propofol intravenous infusion.