Healthy VolunteersPhase 1NCT03936166
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers
A Phase 1 study testing CRN01941 Oral Solution and CRN01941 Oral Capsule in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in Australia.
Trial summary
This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CRN01941 Oral Solution and CRN01941 Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Apr 2019to 16 Dec 2019
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).
- Males and females subjects 65 to 85 years of age at screening (Part 3 only).
- Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by follicle stimulating hormone (FSH) >30 U/L at Screening, or surgically sterile.
- Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
- Willing to provide signed informed consent.
Who cannot join
- Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.
- History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.
- Use of any investigational drug within the past 60 days.
- Have a medically significant abnormality observed during screening or admission.
- Use of any prior medication without approval of the investigator within 14 days prior to admission.
- Subjects with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections. Subjects with previous hepatitis C infection that is now cured may be eligible.
- History of or current alcohol or substance abuse in the past 12 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.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers
This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
- Conditions
- Healthy Volunteers
- Being tested
- CRN01941 Oral Solution, CRN01941 Oral Capsule, Placebo Oral Solution, Placebo Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRN01941 Oral SolutionDrug
Investigational drug
CRN01941 Oral CapsuleDrug
Investigational drug
Placebo Oral SolutionDrug
Placebo
Placebo Oral CapsuleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (Part 1) | Experimental | Not described Receives: Drug: CRN01941 Oral Solution; Drug: CRN01941 Oral Capsule; Drug: Placebo Oral Solution; Drug: Placebo Oral Capsule |
| Multiple Ascending Dose (Part 2) | Experimental | Not described Receives: Drug: CRN01941 Oral Solution; Drug: CRN01941 Oral Capsule; Drug: Placebo Oral Solution; Drug: Placebo Oral Capsule |
| Elderly Cohort (Part 3) | Placebo comparator | Not described Receives: Drug: CRN01941 Oral Solution; Drug: CRN01941 Oral Capsule; Drug: Placebo Oral Solution; Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events by severity
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with serious adverse events (SAEs)
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinically significant changes in vital signs
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with ECG abnormalities
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinical laboratory abnormalities
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary outcomes (4)
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CRN01941
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of CRN01941
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (Tmax)
Assessment of the time to reach Cmax for CRN01941
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (T1/2)
Assessment of the elimination half-life of CRN01941
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start29 Apr 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936166
- Sponsor's protocol ID
- CRN01941-01
- Status last verified
- Nov 2020
- First submitted
- 25 Apr 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03936166
- Acronym / sponsor ID
- CRN01941-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 3 May 2019 (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.
This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single and multiple-dose cohorts are placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (Part 1) | Experimental | Drug: CRN01941 Oral Solution, Drug: CRN01941 Oral Capsule, Drug: Placebo Oral Solution, Drug: Placebo Oral Capsule |
| Multiple Ascending Dose (Part 2) | Experimental | Drug: CRN01941 Oral Solution, Drug: CRN01941 Oral Capsule, Drug: Placebo Oral Solution, Drug: Placebo Oral Capsule |
| Elderly Cohort (Part 3) | Placebo comparator | Drug: CRN01941 Oral Solution, Drug: CRN01941 Oral Capsule, Drug: Placebo Oral Solution, Drug: Placebo Oral Capsule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).
- Males and females subjects 65 to 85 years of age at screening (Part 3 only).
- Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by follicle stimulating hormone (FSH) >30 U/L at Screening, or surgically sterile.
- Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
Key exclusion criteria (8 listed)
- Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.
- History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.
- Use of any investigational drug within the past 60 days.
- Have a medically significant abnormality observed during screening or admission.
- 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 |
|---|---|---|
| CRN01941 Oral SolutionInvestigational drug | Drug | Elderly Cohort (Part 3), Multiple Ascending Dose (Part 2), Single Ascending Dose (Part 1) |
| CRN01941 Oral CapsuleInvestigational drug | Drug | Elderly Cohort (Part 3), Multiple Ascending Dose (Part 2), Single Ascending Dose (Part 1) |
| Placebo Oral SolutionPlacebo | Drug | Elderly Cohort (Part 3), Multiple Ascending Dose (Part 2), Single Ascending Dose (Part 1) |
| Placebo Oral CapsulePlacebo | Drug | Elderly Cohort (Part 3), Multiple Ascending Dose (Part 2), Single Ascending Dose (Part 1) |
Primary outcome
Number of participants with treatment emergent adverse events by severity
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with serious adverse events (SAEs)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinically significant changes in vital signs
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with ECG abnormalities
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinical laboratory abnormalities
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
4 secondary outcomes
Pharmacokinetics (AUC)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (Cmax)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (Tmax)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (T1/2)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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 4 Nov 2020.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
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 CRN01941 Oral Solution and CRN01941 Oral Capsule 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 6 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 4 Nov 2020. 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?
Number of participants with treatment emergent adverse events by severity (time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2020.