Healthy VolunteersPhase 1NCT03276858

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

A Phase 1 study testing CRN00808 and Midazolam oral solution in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: CRN00808 and Midazolam oral solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteAustralia
Study dates: 22 Sep 2017to 30 Apr 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network
Melbourne, Victoria

Other trials in Australia

About this study

Official 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

Read the detailed description

The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels and GHRH-analog stimulated GH levels will be assessed as pharmacodynamics measures.

The first multiple-dose (7 days dosing) cohort will be initiated after the PK and safety data are available from the single-dose phase. Subsequent multiple-dose cohorts will have 10 days of dosing. Serum IGF-1 level and GH levels will be assessed as pharmacodynamics measures.

The last cohort in the study is midazolam drug-drug interaction study. The dose will be selected based on review of all pharmacokinetic and safety data for the single-dose and multiple-dose cohorts completed. On Day 1, 8 subjects will receive a single oral 2 mg dose of midazolam. Starting on Day 3 through Day 8, subjects will receive daily doses of CRN00808. On Day 9, subjects will be administered CRN00808 and 2 mg midazolam together.

Conditions: Healthy Volunteers
Being tested: CRN00808, Placebo Oral Solution, Midazolam oral solution, Placebo oral capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRN00808Drug
Investigational drug
Placebo Oral SolutionDrug
Placebo
Midazolam oral solutionDrug
Midazolam as part of the drug-drug interaction arm of the study
Placebo oral capsuleDrug
Placebo

Study groups in NCT03276858
Study group	Role	What they receive
CRN00808 Oral Solution	Experimental	CRN00808 oral solution, single-dose Receives: Drug: CRN00808
CRN00808 Oral Capsule	Experimental	CRN00808 oral capsule, single-dose and multiple-doses Receives: Drug: CRN00808
Placebo Oral Solution	Placebo comparator	Placebo oral solution, single-dose Receives: Drug: Placebo Oral Solution
Placebo Oral Capsule	Placebo comparator	Placebo oral capsule, single-dose and multiple doses Receives: 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 Receives: Drug: CRN00808; Drug: Midazolam oral solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Day 1 through Day 21

Secondary outcomes (17)

AUC of CRN00808 single ascending doses
plasma AUC
Measured: Day 1 through Day 7
Cmax of CRN00808 single ascending doses
plasma Cmax
Measured: Day 1 through Day 7
t1/2 of CRN00808 single ascending doses
plasma t1/2
Measured: Day 1 through Day 7
Tmax of CRN00808 single ascending doses
plasma Tmax
Measured: Day 1 through Day 7
AUC of CRN00808 multiple ascending doses
plasma AUC
Measured: Day 1 through Day 20
Cmax of CRN00808 multiple ascending doses
plasma Cmax
Measured: Day 1 through Day 20
t1/2 of CRN00808 multiple ascending doses
plasma t1/2
Measured: Day 1 through Day 20
Tmax of CRN00808 multiple ascending doses
plasma Tmax
Measured: Day 1 through Day 20
Pharmacodynamics of CRN00808 in single ascending dose cohorts assessed by GHRH analog stimulated GH levels
Suppression of serum GH induced by a GH secretagogue
Measured: Day -1 and Day 1
Effect of CRN00808 on pharmacokinetics of midazolam
midazolam plasma AUC
Measured: Day 1 through Day 10
Effect of CRN00808 on Cmax of midazolam
midazolam plasma Cmax
Measured: Day 1 through Day 10
Effect of CRN00808 on t1/2 of midazolam
midazolam plasma t 1/2
Measured: Day 1 through Day 10
Effect of CRN00808 on Tmax of midazolam
midazolam plasma Tmax
Measured: Day 1 through Day 10
Relative bioavailability of capsule formulation
single-dose crossover arm only
Measured: Day 1 to Day 7
Effect of food on Cmax of CRN00808
plasma Cmax compared with and without food in single dose arm
Measured: Day 1 to Day 7
Effect of food on AUC of CRN00808
Plasma AUC compared with and without food in single dose arm
Measured: Day 1 to Day 7
Pharmacodynamics of CRN00808 in multiple ascending dose cohorts assessed by serum IGF-1 and GH
serum IGF-1 and GH
Measured: Day -1 to Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 201730 Apr 2018

First posted8 Sep 2017
Study start22 Sep 2017
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single and multiple-dose cohorts are placebo-controlled. The midazolam cohort does not have placebo.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03276858
Sponsor's protocol ID: CRN00808-01
Status last verified: Aug 2018
First submitted: 5 Sep 2017
Last updated: 29 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 35000098

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03276858
Acronym / sponsor ID: CRN00808-01
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 22 Sep 2017 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 8 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: Single and multiple-dose cohorts are placebo-controlled. The midazolam cohort does not have placebo.

Arm	Type	Receives
CRN00808 Oral Solution	Experimental	Drug: CRN00808CRN00808 oral solution, single-dose
CRN00808 Oral Capsule	Experimental	Drug: CRN00808CRN00808 oral capsule, single-dose and multiple-doses
Placebo Oral Solution	Placebo comparator	Drug: Placebo Oral SolutionPlacebo oral solution, single-dose
Placebo Oral Capsule	Placebo comparator	Drug: Placebo oral capsulePlacebo oral capsule, single-dose and multiple doses
Midazolam Oral Solution	Other	Drug: CRN00808, Drug: Midazolam oral solutionMidazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CRN00808Investigational drug	Drug	CRN00808 Oral Capsule, CRN00808 Oral Solution, Midazolam Oral Solution
Placebo Oral SolutionPlacebo	Drug	Placebo Oral Solution
Midazolam oral solutionMidazolam as part of the drug-drug interaction arm of the study	Drug	Midazolam Oral Solution
Placebo oral capsulePlacebo	Drug	Placebo Oral Capsule

Primary outcome

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
Time frame: Day 1 through Day 10
ECG, clinical laboratory parameters, vital signs, physical examinations, telemetry, Holter monitoring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 multiple ascending doses using clinical assessments and subject self-reporting
Time frame: Day 1 through Day 21
ECG, clinical laboratory parameters, vital signs, physical examinations

17 secondary outcomes

AUC of CRN00808 single ascending doses
Time frame: Day 1 through Day 7
Cmax of CRN00808 single ascending doses
Time frame: Day 1 through Day 7
t1/2 of CRN00808 single ascending doses
Time frame: Day 1 through Day 7
Tmax of CRN00808 single ascending doses
Time frame: Day 1 through Day 7
AUC of CRN00808 multiple ascending doses
Time frame: Day 1 through Day 20
Cmax of CRN00808 multiple ascending doses
Time frame: Day 1 through Day 20
t1/2 of CRN00808 multiple ascending doses
Time frame: Day 1 through Day 20
Tmax of CRN00808 multiple ascending doses
Time frame: Day 1 through Day 20
Pharmacodynamics of CRN00808 in single ascending dose cohorts assessed by GHRH analog stimulated GH levels
Time frame: Day -1 and Day 1
Effect of CRN00808 on pharmacokinetics of midazolam
Time frame: Day 1 through Day 10
Effect of CRN00808 on Cmax of midazolam
Time frame: Day 1 through Day 10
Effect of CRN00808 on t1/2 of midazolam
Time frame: Day 1 through Day 10
Effect of CRN00808 on Tmax of midazolam
Time frame: Day 1 through Day 10
Relative bioavailability of capsule formulation
Time frame: Day 1 to Day 7
Effect of food on Cmax of CRN00808
Time frame: Day 1 to Day 7
Effect of food on AUC of CRN00808
Time frame: Day 1 to Day 7
Pharmacodynamics of CRN00808 in multiple ascending dose cohorts assessed by serum IGF-1 and GH
Time frame: Day -1 to Day 21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Derived from this study: PubMed 35000098Madan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason Lickliter, MBBS PhD principal investigator

Nucleus Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CRN00808 and Midazolam oral solution in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 1 through Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03276858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.