Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
Completed
Crinetics Pharmaceuticals Inc.
Phase 1
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).
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Completed
Crinetics Pharmaceuticals Inc.
Phase 2
An open label exploratory study designed to evaluate the safety, efficacy, and
pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin
receptor type 2 biased agonist) in subjects with acromegaly that are treated with
somatostatin analogue (SSA) based treatment regimens.
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
Completed
Crinetics Pharmaceuticals Inc.
Phase 2
A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to
evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an
oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with
acromegaly that are responders to octreotide LAR or lanreotide depot.
Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers
Completed
Crinetics Pharmaceuticals Inc.
Phase 1
A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic
profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the
absorption, distribution, metabolism, excretion, and mass balance of orally administered
radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808
administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.
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