Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers

Phase 1 Completed 99 enrolled Crinetics Pharmaceuticals Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase (one cohort of 8 subjects).

Timeline

Start: 2017-09-22
Primary completion: 2018-04-30
Completion: 2018-04-30

Publications

Madan A, Markison S, Betz SF, Krasner A, Luo R, Jochelson T, Lickliter J, Struthers RS. Paltusotine, a novel oral once-daily nonpeptide SST2 receptor agonist, suppresses GH and IGF-1 in healthy volunteers. Pituitary. 2022 Apr;25(2):328-339. doi: 10.1007/s11102-021-01201-z. Epub 2022 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam oral solution	Unknown	2 mg	Oral
Subject	Paltusotine	Small molecule	1.25 mg	Oral
Subject	Paltusotine	Small molecule	2.5 mg	Oral
Subject	Paltusotine	Small molecule	5 mg	Oral
Subject	Paltusotine	Small molecule	10 mg	Oral
Subject	Paltusotine	Small molecule	20 mg	Oral
Subject	Paltusotine	Small molecule	30 mg	Oral
Subject	Paltusotine	Small molecule	40 mg	Oral
Subject	Paltusotine	Small molecule	60 mg	Oral

Indications

No indication recorded.