A Phase 1 interventional study of CRN00808 and Placebo Oral Solution in Healthy Volunteers, sponsored by Crinetics Pharmaceuticals Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Crinetics Pharmaceuticals Inc. (part of Vertex Pharmaceuticals Incorporated) · Phase 1, Interventional, and Treatment
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).
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.
Crinetics Pharmaceuticals Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
First submitted before Crinetics Pharmaceuticals Inc. became part of Vertex Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CRN00808 oral solution, single-dose
Drug: CRN00808
CRN00808 oral capsule, single-dose and multiple-doses
Drug: CRN00808
Placebo oral solution, single-dose
Drug: Placebo Oral Solution
Placebo oral capsule, single-dose and multiple doses
Drug: Placebo oral capsule
Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study
Drug: CRN00808 · Drug: Midazolam oral solution
Investigational drug
Placebo
Midazolam as part of the drug-drug interaction arm of the study
Placebo
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
Time frame: 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
Time frame: Day 1 through Day 21
AUC of CRN00808 single ascending doses
plasma AUC
Time frame: Day 1 through Day 7
Cmax of CRN00808 single ascending doses
plasma Cmax
Time frame: Day 1 through Day 7
t1/2 of CRN00808 single ascending doses
plasma t1/2
Time frame: Day 1 through Day 7
Tmax of CRN00808 single ascending doses
plasma Tmax
Time frame: Day 1 through Day 7
AUC of CRN00808 multiple ascending doses
plasma AUC
Time frame: Day 1 through Day 20
Cmax of CRN00808 multiple ascending doses
plasma Cmax
Time frame: Day 1 through Day 20
t1/2 of CRN00808 multiple ascending doses
plasma t1/2
Time frame: Day 1 through Day 20
Tmax of CRN00808 multiple ascending doses
plasma Tmax
Time frame: 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
Time frame: Day -1 and Day 1
Effect of CRN00808 on pharmacokinetics of midazolam
midazolam plasma AUC
Time frame: Day 1 through Day 10
Effect of CRN00808 on Cmax of midazolam
midazolam plasma Cmax
Time frame: Day 1 through Day 10
Effect of CRN00808 on t1/2 of midazolam
midazolam plasma t 1/2
Time frame: Day 1 through Day 10
Effect of CRN00808 on Tmax of midazolam
midazolam plasma Tmax
Time frame: Day 1 through Day 10
Relative bioavailability of capsule formulation
single-dose crossover arm only
Time frame: Day 1 to Day 7
Effect of food on Cmax of CRN00808
plasma Cmax compared with and without food in single dose arm
Time frame: Day 1 to Day 7
Effect of food on AUC of CRN00808
Plasma AUC compared with and without food in single dose arm
Time frame: 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
Time frame: Day -1 to Day 21
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paltusotine
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