Healthy VolunteersPhase 1NCT04246749
Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers
A Phase 1 study testing [14C]-CRN00808 and CRN00808 in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-CRN00808 and CRN00808
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2019to 25 Oct 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects 19 to 55 years of age
- BMI 18 to 30 kg/m2
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.
About this study
Official title: A Phase 1, Open-label, Two-cohort, Single Dose Study to Assess the Mass Balance, Route of Elimination, and Metabolic Profile of [14C] Labeled CRN00808 and Absolute Bioavailability of CRN00808 in Healthy Male Volunteers
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.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-CRN00808, CRN00808
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-CRN00808Drug
Investigational drug
CRN00808Drug
Investigational drug
| Study group | Role | What they receive |
|---|---|---|
| Part A: [14C]-CRN00808 Oral Solution | Experimental | Single oral dose of CRN00808 containing [14C]-CRN00808 Receives: Drug: [14C]-CRN00808 |
| Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer | Experimental | Single oral dose of CRN00808 followed by [14C]-CRN00808 IV microtracer injection Receives: Drug: [14C]-CRN00808; Drug: CRN00808 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of CRN00808
Total radioactivity in urine and feces following a single oral dose [14C]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Measured: Up to 21 days (until >90% of dose is recovered)
Absolute bioavailability of CRN00808
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
Measured: 5 days
Secondary outcomes (7)
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CRN00808 and [14C]-CRN00808
Measured: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (t1/2)
Assessment of the total elimination half-life of CRN00808 and [14C]-CRN00808
Measured: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (Tmax)
Assessment of Time to attain maximum observed plasma concentration of CRN00808 and [14C]-CRN00808
Measured: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (CL)
Assessment of the clearance of CRN00808 (Part B only)
Measured: Day 1 through to Day 7
Pharmacokinetics (CL/F)
Assessment of Apparent oral clearance of CRN00808
Measured: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (Vz)
Assessment of Volume of distribution at terminal phase (Part B only)
Measured: Day 1 through to Day 7
Pharmacokinetics (Vz/F)
Assessment of Apparent volume of distribution at terminal phase
Measured: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start17 Sep 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT04246749
- Sponsor's protocol ID
- CRN00808-06
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 29 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Two-cohort, Single Dose Study to Assess the Mass Balance, Route of Elimination, and Metabolic Profile of [14C] Labeled CRN00808 and Absolute Bioavailability of CRN00808 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04246749
- Acronym / sponsor ID
- CRN00808-06
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 29 Jan 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: [14C]-CRN00808 Oral Solution | Experimental | Drug: [14C]-CRN00808Single oral dose of CRN00808 containing [14C]-CRN00808 |
| Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer | Experimental | Drug: [14C]-CRN00808, Drug: CRN00808Single oral dose of CRN00808 followed by [14C]-CRN00808 IV microtracer injection |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male subjects 19 to 55 years of age
- BMI 18 to 30 kg/m2
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 |
|---|---|---|
| [14C]-CRN00808Investigational drug | Drug | Part A: [14C]-CRN00808 Oral Solution, Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer |
| CRN00808Investigational drug | Drug | Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer |
Primary outcome
Mass balance of CRN00808
Time frame: Up to 21 days (until >90% of dose is recovered)
Total radioactivity in urine and feces following a single oral dose [14C]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability of CRN00808
Time frame: 5 days
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
7 secondary outcomes
Pharmacokinetics (AUC)
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (t1/2)
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (Tmax)
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (CL)
Time frame: Day 1 through to Day 7
Pharmacokinetics (CL/F)
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Pharmacokinetics (Vz)
Time frame: Day 1 through to Day 7
Pharmacokinetics (Vz/F)
Time frame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
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 Jan 2020.
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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.
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 [14C]-CRN00808 and CRN00808 in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in Netherlands.
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 Jan 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 Netherlands. 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. 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?
Mass balance of CRN00808 (time frame: Up to 21 days (until >90% of dose is recovered)). 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?
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 Jan 2020.