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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03276858




Registration number
NCT03276858
Ethics application status
Date submitted
5/09/2017
Date registered
8/09/2017
Date last updated
29/08/2018

Titles & IDs
Public title
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Dose Study to Evaluate the Safety, PK, and PD of CRN00808 in Healthy Volunteers and to Determine the Effect of CRN00808 on Midazolam PK
Secondary ID [1] 0 0
CRN00808-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CRN00808
Treatment: Drugs - Placebo Oral Solution
Treatment: Drugs - Midazolam oral solution
Treatment: Drugs - Placebo oral capsule

Experimental: CRN00808 Oral Solution - CRN00808 oral solution, single-dose

Experimental: CRN00808 Oral Capsule - CRN00808 oral capsule, single-dose and multiple-doses

Placebo comparator: Placebo Oral Solution - Placebo oral solution, single-dose

Placebo comparator: Placebo Oral Capsule - Placebo oral capsule, single-dose and multiple doses

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


Treatment: Drugs: CRN00808
Investigational drug

Treatment: Drugs: Placebo Oral Solution
Placebo

Treatment: Drugs: Midazolam oral solution
Midazolam as part of the drug-drug interaction arm of the study

Treatment: Drugs: Placebo oral capsule
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 1 through Day 10
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 multiple ascending doses using clinical assessments and subject self-reporting
Timepoint [2] 0 0
Day 1 through Day 21
Secondary outcome [1] 0 0
AUC of CRN00808 single ascending doses
Timepoint [1] 0 0
Day 1 through Day 7
Secondary outcome [2] 0 0
Cmax of CRN00808 single ascending doses
Timepoint [2] 0 0
Day 1 through Day 7
Secondary outcome [3] 0 0
t1/2 of CRN00808 single ascending doses
Timepoint [3] 0 0
Day 1 through Day 7
Secondary outcome [4] 0 0
Tmax of CRN00808 single ascending doses
Timepoint [4] 0 0
Day 1 through Day 7
Secondary outcome [5] 0 0
AUC of CRN00808 multiple ascending doses
Timepoint [5] 0 0
Day 1 through Day 20
Secondary outcome [6] 0 0
Cmax of CRN00808 multiple ascending doses
Timepoint [6] 0 0
Day 1 through Day 20
Secondary outcome [7] 0 0
t1/2 of CRN00808 multiple ascending doses
Timepoint [7] 0 0
Day 1 through Day 20
Secondary outcome [8] 0 0
Tmax of CRN00808 multiple ascending doses
Timepoint [8] 0 0
Day 1 through Day 20
Secondary outcome [9] 0 0
Pharmacodynamics of CRN00808 in single ascending dose cohorts assessed by GHRH analog stimulated GH levels
Timepoint [9] 0 0
Day -1 and Day 1
Secondary outcome [10] 0 0
Effect of CRN00808 on pharmacokinetics of midazolam
Timepoint [10] 0 0
Day 1 through Day 10
Secondary outcome [11] 0 0
Effect of CRN00808 on Cmax of midazolam
Timepoint [11] 0 0
Day 1 through Day 10
Secondary outcome [12] 0 0
Effect of CRN00808 on t1/2 of midazolam
Timepoint [12] 0 0
Day 1 through Day 10
Secondary outcome [13] 0 0
Effect of CRN00808 on Tmax of midazolam
Timepoint [13] 0 0
Day 1 through Day 10
Secondary outcome [14] 0 0
Relative bioavailability of capsule formulation
Timepoint [14] 0 0
Day 1 to Day 7
Secondary outcome [15] 0 0
Effect of food on Cmax of CRN00808
Timepoint [15] 0 0
Day 1 to Day 7
Secondary outcome [16] 0 0
Effect of food on AUC of CRN00808
Timepoint [16] 0 0
Day 1 to Day 7
Secondary outcome [17] 0 0
Pharmacodynamics of CRN00808 in multiple ascending dose cohorts assessed by serum IGF-1 and GH
Timepoint [17] 0 0
Day -1 to Day 21

Eligibility
Key inclusion criteria
* BMI 18 to 30 kg/m2
* Females postmenopausal or surgically sterile
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2018
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Crinetics Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT03276858
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MBBS PhD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03276858