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

NCT03276858 | Completed Phase 1 DMC

• 1 other identifier: CRN00808-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 single ascending doses using clinical assessments, telemetry, and Holter monitoring and subject self-reporting

  ECG, clinical laboratory parameters, vital signs, physical examinations, telemetry, Holter monitoring

  Day 1 through Day 10

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 multiple ascending doses using clinical assessments and subject self-reporting

  ECG, clinical laboratory parameters, vital signs, physical examinations

  Day 1 through Day 21

Secondary Outcomes (17)

• AUC of CRN00808 single ascending doses

  Day 1 through Day 7

• Cmax of CRN00808 single ascending doses

  Day 1 through Day 7

• t1/2 of CRN00808 single ascending doses

  Day 1 through Day 7

• Tmax of CRN00808 single ascending doses

  Day 1 through Day 7

• AUC of CRN00808 multiple ascending doses

  Day 1 through Day 20

Study Arms (5)

CRN00808 Oral Solution

EXPERIMENTAL

CRN00808 oral solution, single-dose

Drug: CRN00808

CRN00808 Oral Capsule

EXPERIMENTAL

CRN00808 oral capsule, single-dose and multiple-doses

Drug: CRN00808

Placebo Oral Solution

PLACEBO COMPARATOR

Placebo oral solution, single-dose

Drug: Placebo Oral Solution

Placebo Oral Capsule

PLACEBO COMPARATOR

Placebo oral capsule, single-dose and multiple doses

Drug: Placebo oral capsule

Midazolam Oral Solution

OTHER

Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study

Drug: CRN00808; Drug: Midazolam oral solution

Interventions

CRN00808 DRUG

Investigational drug

CRN00808 Oral Capsule; CRN00808 Oral Solution; Midazolam Oral Solution

Placebo Oral Solution DRUG

Placebo

Placebo Oral Solution

Midazolam oral solution DRUG

Midazolam as part of the drug-drug interaction arm of the study

Midazolam Oral Solution

Placebo oral capsule DRUG

Placebo

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18 to 30 kg/m2
• Females postmenopausal or surgically sterile

You may not qualify if:

• Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
• History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
• Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
• Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
• Use of any prior medication without approval of the investigator within 14 days prior to admission
• Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
• History of alcohol or substance abuse in the past 6 months
• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, Australia

Location

Related Publications (1)

• 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.

  PMID: 35000098 DERIVED

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jason Lickliter, MBBS PhD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single and multiple-dose cohorts are placebo-controlled. The midazolam cohort does not have placebo.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: September 22, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)