HealthyPhase 1NCT03315338
First-in-human Study in Healthy Subjects
A Phase 1 study testing CORT118335, 25 mg, Prednisone Oral Tablet and Glucose in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.
Trial summary
This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CORT118335, 25 mg, Prednisone Oral Tablet and Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2017to 22 Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects or non-pregnant, non-lactating healthy female subjects of non-childbearing potential
- Age 18 to 60 years
- Body mass index (BMI) of 18.0 to 30.0 kg/m2
- Weight of ≤102 kg
- Must be willing and able to communicate and participate in the whole study
- Morning serum cortisol of 5 μg/dL to 23 μg/dL (138 nmol/L to 635 nmol/L) at screening and/or Day -1 for multiple dose cohorts
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- Must provide written informed consent
- Must agree to use an adequate method of contraception
- Must agree to adhere to study restrictions
Who cannot join
- Subjects who have received any IMP in a clinical research study within the 3 months before the first dose in this study
- Subjects who are study site or Sponsor employees, or immediate family members of a study site or Sponsor employee
- Subjects who have previously been enrolled in this study
- Males who have a pregnant partner
- History of any drug or alcohol abuse in the year before the first dose in this study
- Regular alcohol consumption in male subjects >21 units per week and female subjects >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
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- Current smokers and those who have smoked within the 6 months before the first dose in this study. A breath carbon monoxide reading of greater than 10 ppm at screening or on admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the 6 months before the first dose in this study
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening
- Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the Investigator
- Positive drugs of abuse test result at screening or on admission (amphetamines, barbiturates, benzodiazepines, cocaine, marijuana/cannabis, methadone, methamphetamine/ecstasy, morphine/opiates, phencyclidine, tricyclic antidepressants)
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Subject has active renal and/or hepatic disease, as evidenced by:
- an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 using Modification of Diet in Renal Disease (MDRD) equation at screening
- ALT and/or AST >1.5 times the upper limit of normal at screening or on admission
- subjects with borderline results can have these tests repeated once.
- History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal or neurological disease as judged by the Investigator
- Subject had any form of cancer within the 2 years before first dose in this study*, with the exception of basal cell and/or squamous cell cancer of the skin that has been treated completely and is without evidence of local recurrence or metastasis
- Subject has a history and/or symptoms of adrenal insufficiency
- Subject has consumed liquorice or other glycyrrhetic acid derivatives regularly, in the judgement of the Investigator, in the 6 months before the first dose of study medication
- Subject has a history of jaundice and/or subject has had a cholecystectomy
- Subject has a history of clinically significant gastrointestinal disease including gastroesophageal reflux disease, malabsorption syndrome, colon cancer, chronic colitis, Crohn's disease, inflammatory bowel disease, gastroparesis, constipation, chronic diarrhoea, obstruction, gastrointestinal bleeding, and/or peptic ulcers
- Subject has a condition that could be aggravated by glucocorticoid and/or mineralocorticoid blockade (e.g., asthma, any chronic inflammatory condition) or activation (e.g., immunodeficiency, active infection)
- Subjects with inactive seasonal hay fever may be included. Subjects with childhood (aged less than 18 years) asthma may be included provided they have had no symptoms and required no treatment for at least 5 years
- Subjects with a QTcF interval of >450 msec at screening or pre-dose, based on the mean of three ECGs
- History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome)
- Supine heart rate at rest of <40 bpm or >100 bpm. BP out with the following ranges: diastolic BP 40-90; systolic BP 90-140 (subjects aged 18-45 year) and 90-160 (subjects aged >45 year). Heart rate and blood pressure can be retested twice in the supine position at intervals of 5 min on a given day at screening and admission.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients including glucose/fructose intolerance for the standard oral glucose tolerance test (OGTT)
- Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator.
- Donation or loss of greater than 400 mL of blood within the 3 months before first study dose
- Subjects who are taking, or have taken, any prescribed, over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies within 14 days, or for which 5 times the medication's elimination half-life will not be completed if longer, before the first dose of study medication. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the Investigator and Sponsor's medical monitor. Standard dose multivitamins are permitted throughout the study period
- Subjects who are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
- Subjects who are taking, or have taken enzyme inducers within 30 days before the first dose of study medication
- Subject is expected to require use of any medication (with the exception of standard dose multivitamins) during the study period
- Subject has a history or presence of any medical condition or disease which, in the opinion of the Investigator, could interfere with the conduct of the study or could put the subject at unacceptable risk. This specifically includes any subject with flu or flu-like symptoms
- Failure to satisfy the Investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: A Phase I Adaptive Dose, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT118335 in Healthy Subjects
This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects.
Read the detailed description
This is a 5-part, single-center study of single and multiple ascending doses of CORT118335 in healthy subjects.
Parts I and 4 of the study are double-blind, randomized, placebo-controlled assessments of single-ascending doses (SAD) of CORT118335. Subjects will be enrolled sequentially into 1 of up 8 cohorts (Part 1, Cohorts A to D [Cohorts E to G have been cancelled]; Part 4, Cohorts A to D), each containing 8 subjects. Within each cohort, 6 subjects will be randomly assigned to receive a single dose of CORT118335 and 2 subjects will be randomly assigned to receive a single dose of matching placebo.
Part 2 Cohort A, food-effect, will be an open-label 2-way crossover study in one cohort of 12 subjects, randomized in a 1:1 ratio to receive a single dose of CORT118335 once after an overnight fast and once after a high-fat breakfast or the alternate sequence, over 2 study periods separated by a washout of at least 7 days/5 half-lives.
Part 2 Cohort B, PD cohort, will be a double-blind, randomized, placebo-controlled, 3-way cross-over study and will serve as proof of pharmacological effect (GR modulation) for CORT118335. Subjects will be randomized in a 1:1:1 ratio to receive placebo, and two dose levels of CORT118335 in one of three treatment sequences across 3 study periods separated by washouts of at least 7 days/5 half-lives. On each occasion, the ability of CORT118335 to ameliorate the pharmacological effects of a single dose of prednisone will be measured.
Parts 3 and 5 are double-blind, randomized, placebo-controlled assessments of multiple oral ascending doses of CORT118335. Subjects will be enrolled sequentially into 1 of up to 4 cohorts (Part 1 Cohort A [Cohorts B to D have been cancelled; Part 5 Cohorts A to C), each containing 12 subjects. Within each cohort, 9 subjects will be randomly assigned to receive CORT118335 and 3 subjects to receive matching placebo daily for 14 days.
Different formulations of CORT118335 will be used in Parts 1, 2 and 3, and in Parts 4 and 5.
- Conditions
- Healthy
- Being tested
- CORT118335, 25 mg, Prednisone Oral Tablet, Glucose, Placebo oral suspension, CORT118335, 75mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORT118335, 25 mgDrug
CORT118335 is supplied as capsules for oral dosing
Prednisone Oral TabletDrug
Challenge Agent, Dose and Route of Administration:
Standard release 1x20mg and 1x5mg (25mg total) dose, orally administered.
GlucoseDrug
75 g in 300 mL solution, orally administered
Placebo oral suspensionDrug
Reference Therapy, Dose and Route of Administration:
Placebo suspension, orally administered.
CORT118335, 75mgDrug
CORT118335 is supplied as capsules for oral dosing
CORT118335, 225mgDrug
CORT118335 is supplied as capsules for oral dosing
CORT118335, 675mgDrug
CORT118335 is supplied as capsules for oral dosing
CORT118335, 600mgDrug
CORT118335 is supplied as capsules for oral dosing
CORT118335, 630mgDrug
CORT118335 is supplied as capsules for oral dosing
CORT118335, 375mgDrug
CORT118335 is supplied as capsules for oral dosing
CORT118335, 100mgDrug
CORT118335 is supplied as a suspension for oral dosing
CORT118335, 300mgDrug
CORT118335 is supplied as a suspension for oral dosing
CORT118335, 900mgDrug
CORT118335 is supplied as a suspension for oral dosing
CORT118335, 150mgDrug
CORT118335 is supplied as a suspension for oral dosing
CORT118335, 1500mgDrug
CORT118335 is supplied as a suspension for oral dosing
Placebo oral capsuleDrug
Placebo capsules, orally administered
CORT118335, dose to be determinedDrug
CORT118335 is supplied as suspension for oral dosing
| Study group | Role | What they receive |
|---|---|---|
| SAD Part 1 Active Cohort A | Experimental | CORT118335, 25 mg Receives: Drug: CORT118335, 25 mg |
| SAD Part 1 Placebo oral capsule Cohort A | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| SAD Part 1 Active Cohort B | Experimental | CORT118335, 75mg Receives: Drug: CORT118335, 75mg |
| SAD Part 1 Placebo Cohort B | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| SAD Part 1 Active Cohort C | Experimental | CORT118335, 225mg Receives: Drug: CORT118335, 225mg |
| SAD Part 1 Placebo Cohort C | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| SAD Part 1 Active Cohort D | Experimental | CORT118335, 675mg Receives: Drug: CORT118335, 675mg |
| SAD Part 1 Placebo Cohort D | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| SAD Part 2 Active Cohort A, Fasting | Experimental | CORT118335, 600mg, is supplied as capsules for oral dosing given after an overnight fast Receives: Drug: CORT118335, 600mg |
| SAD Part 2 Active Cohort A, Fed | Experimental | CORT118335, 600mg, is supplied as capsules for oral dosing given after a high-fat breakfast Receives: Drug: CORT118335, 600mg |
| SAD Part 2 Placebo PD Effect Cohort B | Placebo comparator | Not described Receives: Drug: Prednisone Oral Tablet; Drug: Glucose; Drug: Placebo oral capsule |
| SAD Part 2 Active PD Effect Cohort B: 630mg of CORT118335 | Experimental | Not described Receives: Drug: Prednisone Oral Tablet; Drug: Glucose; Drug: CORT118335, 630mg |
| SAD Part 2 Active PD Effect Cohort B: 675mg of CORT118335 | Experimental | Not described Receives: Drug: Prednisone Oral Tablet; Drug: Glucose; Drug: CORT118335, 675mg |
| MAD Part 3 Active Cohort A | Experimental | CORT118335, 375mg qd for 14 days Receives: Drug: CORT118335, 375mg |
| MAD Part 3 Placebo Cohort A | Placebo comparator | Placebo qd for 14 days Receives: Drug: Placebo oral capsule |
| SAD Part 4 Active Cohort A | Experimental | CORT118335, 100mg Receives: Drug: CORT118335, 100mg |
| SAD Part 4 Placebo Cohort A | Placebo comparator | Not described Receives: Drug: Placebo oral suspension |
| SAD Part 4 Active Cohort B | Experimental | CORT118335, 300mg Receives: Drug: CORT118335, 300mg |
| SAD Part 4 Placebo Cohort B | Placebo comparator | Not described Receives: Drug: Placebo oral suspension |
| SAD Part 4 Active Cohort C, Fasting | Experimental | CORT118335, 900mg is supplied as suspension for oral dosing given after an overnight fast Receives: Drug: CORT118335, 900mg |
| SAD Part 4 Active Cohort C, Fed | Experimental | CORT118335, 900mg is supplied as suspension for oral dosing given after a high-fat breakfast Receives: Drug: CORT118335, 900mg |
| SAD Part 4 Placebo Cohort C, Fasting | Placebo comparator | Supplied as suspension for oral dosing given after an overnight fast Receives: Drug: Placebo oral suspension |
| SAD Part 4 Placebo Cohort C, Fed | Placebo comparator | Supplied as suspension for oral dosing given after a high-fat breakfast Receives: Drug: Placebo oral suspension |
| SAD Part 4 Active Cohort Part D | Experimental | CORT118335, 1500mg Receives: Drug: CORT118335, 1500mg |
| SAD Part 4 Placebo Cohort D | Placebo comparator | Not described Receives: Drug: Placebo oral suspension |
| MAD Part 5 Active Cohort A | Experimental | CORT118335, 150mg Receives: Drug: CORT118335, 150mg |
| MAD Part 5 Placebo Cohort A | Placebo comparator | Not described Receives: Drug: Placebo oral suspension |
| MAD Part 5 Active Cohort B | Experimental | CORT118335, dose to be determined Receives: Drug: CORT118335, dose to be determined |
| MAD Part 5 Placebo Cohort B | Placebo comparator | Not described Receives: Drug: Placebo oral suspension |
| MAD Part 5 Active Cohort C | Experimental | CORT118335, dose to be determined Receives: Drug: CORT118335, dose to be determined |
| MAD Part 5 Placebo Cohort C | Placebo comparator | Not described Receives: Drug: Placebo oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Measured: SAD Cohorts: Day -28 to Day 7; Part 2A Cohorts: Day -28 to Day 14; Part 2B Cohorts: Day -28 to Day 21; MAD Cohorts: Day -28 to Day 21
Secondary outcomes (21)
QT interval corrected for heart rate using Fridericia's formula (QTcF) exposure-response analysis
Measured: SAD parts: Pre dose through 24 hours post dose. MAD parts: Pre first dose through 24 hours post final dose of Investigational Medicinal Product (IMP
tlag Pharmacokinetic (PK) parameter
The elapsed time from dosing at which analyte was first quantifiable in a concentration vs time profile (tlag)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
tmax PK parameter
The time from dosing at which Cmax was apparent (tmax)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
Cmax PK parameter
Maximum observed concentration (Cmax)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
tmin (MAD only) PK parameter
Time from dosing of the minimum plasma drug concentration (tmin)
Measured: MAD parts: Pre first dose through 96 hours post final dose of IMP
Cmin (MAD only) PK parameter
Minimum plasma drug concentration (Cmin)
Measured: MAD parts: Pre first dose through 96 hours post final dose of IMP
Clast PK parameter
Last measurable concentration (Clast)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
tlast PK parameter
Time from dosing of the last measurable concentration (tlast)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
t1/2 PK parameter
The apparent elimination half-life (t1/2)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
lambda-z PK parameter
The slope of the apparent elimination phase (lambda-z)
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
AUCinf PK parameter
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Measured: SAD parts: Pre dose through 96h post dose; MAD parts: Pre first dose through 96h post final dose of IMP
AUC(0-last) PK parameter
Area under the curve from 0 time to last measurable concentration [AUC(0-last)]
Measured: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
AUC(0-24) PK parameter
Area under the curve from 0 time to 24 h post dose [AUC(0-24)]
Measured: SAD parts: Pre dose through 24 hours post dose; MAD parts: Pre first dose through 24 hours post final dose of IMP
Food effect: AUC(0-last) PK parameter
Measured: Pre first dose through 96 hours post final dose
Food effect: AUC(0-inf) PK parameter
Area under the curve from 0 time extrapolated to infinity [AUC(0-inf)]
Measured: Pre first dose through 96 hours post final dose
Food effect: Cmax PK parameter
Measured: Pre first dose through 96 hours post final dose
Pharmacodynamics (PD): peripheral differential white blood cell count
Measured: Pre first dose through 24 hours post final dose
PD: serum osteocalcin and adiponectin concentrations
Measured: Pre first dose through 24 hours post final dose
PD: messenger ribonucleic acid (mRNA) expression for selected genes in whole blood
Measured: Pre first dose through 24 hours post final dose
PD: glucose tolerance
Measured: Pre first dose through 24 hours post final dose
Homeostatic model assessment of insulin-resistance (HOMA-IR)
Measured: Pre-dose through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start15 Sep 2017
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 5 study parts may not be conducted entirely sequentially provided that this is justified by PK and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels using the same formulation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MBChB, MFPM, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315338
- Sponsor's protocol ID
- CORT118335-850
- Status last verified
- May 2019
- First submitted
- 27 Sep 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Adaptive Dose, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT118335 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03315338
- Acronym / sponsor ID
- CORT118335-850
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 20 Oct 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.
This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects.
Detailed description
This is a 5-part, single-center study of single and multiple ascending doses of CORT118335 in healthy subjects.
Parts I and 4 of the study are double-blind, randomized, placebo-controlled assessments of single-ascending doses (SAD) of CORT118335. Subjects will be enrolled sequentially into 1 of up 8 cohorts (Part 1, Cohorts A to D [Cohorts E to G have been cancelled]; Part 4, Cohorts A to D), each containing 8 subjects. Within each cohort, 6 subjects will be randomly assigned to receive a single dose of CORT118335 and 2 subjects will be randomly assigned to receive a single dose of matching placebo.
Part 2 Cohort A, food-effect, will be an open-label 2-way crossover study in one cohort of 12 subjects, randomized in a 1:1 ratio to receive a single dose of CORT118335 once after an overnight fast and once after a high-fat breakfast or the alternate sequence, over 2 study periods separated by a washout of at least 7 days/5 half-lives.
Part 2 Cohort B, PD cohort, will be a double-blind, randomized, placebo-controlled, 3-way cross-over study and will serve as proof of pharmacological effect (GR modulation) for CORT118335. Subjects will be randomized in a 1:1:1 ratio to receive placebo, and two dose levels of CORT118335 in one of three treatment sequences across 3 study periods separated by washouts of at least 7 days/5 half-lives. On each occasion, the ability of CORT118335 to ameliorate the pharmacological effects of a single dose of prednisone will be measured.
Parts 3 and 5 are double-blind, randomized, placebo-controlled assessments of multiple oral ascending doses of CORT118335. Subjects will be enrolled sequentially into 1 of up to 4 cohorts (Part 1 Cohort A [Cohorts B to D have been cancelled; Part 5 Cohorts A to C), each containing 12 subjects. Within each cohort, 9 subjects will be randomly assigned to receive CORT118335 and 3 subjects to receive matching placebo daily for 14 days.
Different formulations of CORT118335 will be used in Parts 1, 2 and 3, and in Parts 4 and 5.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 31
- Model description
- The 5 study parts may not be conducted entirely sequentially provided that this is justified by PK and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels using the same formulation.
| Arm | Type | Receives |
|---|---|---|
| SAD Part 1 Active Cohort A | Experimental | Drug: CORT118335, 25 mgCORT118335, 25 mg |
| SAD Part 1 Placebo oral capsule Cohort A | Placebo comparator | Drug: Placebo oral capsule |
| SAD Part 1 Active Cohort B | Experimental | Drug: CORT118335, 75mgCORT118335, 75mg |
| SAD Part 1 Placebo Cohort B | Placebo comparator | Drug: Placebo oral capsule |
| SAD Part 1 Active Cohort C | Experimental | Drug: CORT118335, 225mgCORT118335, 225mg |
| SAD Part 1 Placebo Cohort C | Placebo comparator | Drug: Placebo oral capsule |
| SAD Part 1 Active Cohort D | Experimental | Drug: CORT118335, 675mgCORT118335, 675mg |
| SAD Part 1 Placebo Cohort D | Placebo comparator | Drug: Placebo oral capsule |
| SAD Part 2 Active Cohort A, Fasting | Experimental | Drug: CORT118335, 600mgCORT118335, 600mg, is supplied as capsules for oral dosing given after an overnight fast |
| SAD Part 2 Active Cohort A, Fed | Experimental | Drug: CORT118335, 600mgCORT118335, 600mg, is supplied as capsules for oral dosing given after a high-fat breakfast |
| SAD Part 2 Placebo PD Effect Cohort B | Placebo comparator | Drug: Prednisone Oral Tablet, Drug: Glucose, Drug: Placebo oral capsule |
| SAD Part 2 Active PD Effect Cohort B: 630mg of CORT118335 | Experimental | Drug: Prednisone Oral Tablet, Drug: Glucose, Drug: CORT118335, 630mg |
| SAD Part 2 Active PD Effect Cohort B: 675mg of CORT118335 | Experimental | Drug: Prednisone Oral Tablet, Drug: Glucose, Drug: CORT118335, 675mg |
| MAD Part 3 Active Cohort A | Experimental | Drug: CORT118335, 375mgCORT118335, 375mg qd for 14 days |
| MAD Part 3 Placebo Cohort A | Placebo comparator | Drug: Placebo oral capsulePlacebo qd for 14 days |
| SAD Part 4 Active Cohort A | Experimental | Drug: CORT118335, 100mgCORT118335, 100mg |
| SAD Part 4 Placebo Cohort A | Placebo comparator | Drug: Placebo oral suspension |
| SAD Part 4 Active Cohort B | Experimental | Drug: CORT118335, 300mgCORT118335, 300mg |
| SAD Part 4 Placebo Cohort B | Placebo comparator | Drug: Placebo oral suspension |
| SAD Part 4 Active Cohort C, Fasting | Experimental | Drug: CORT118335, 900mgCORT118335, 900mg is supplied as suspension for oral dosing given after an overnight fast |
| SAD Part 4 Active Cohort C, Fed | Experimental | Drug: CORT118335, 900mgCORT118335, 900mg is supplied as suspension for oral dosing given after a high-fat breakfast |
| SAD Part 4 Placebo Cohort C, Fasting | Placebo comparator | Drug: Placebo oral suspensionSupplied as suspension for oral dosing given after an overnight fast |
| SAD Part 4 Placebo Cohort C, Fed | Placebo comparator | Drug: Placebo oral suspensionSupplied as suspension for oral dosing given after a high-fat breakfast |
| SAD Part 4 Active Cohort Part D | Experimental | Drug: CORT118335, 1500mgCORT118335, 1500mg |
| SAD Part 4 Placebo Cohort D | Placebo comparator | Drug: Placebo oral suspension |
| MAD Part 5 Active Cohort A | Experimental | Drug: CORT118335, 150mgCORT118335, 150mg |
| MAD Part 5 Placebo Cohort A | Placebo comparator | Drug: Placebo oral suspension |
| MAD Part 5 Active Cohort B | Experimental | Drug: CORT118335, dose to be determinedCORT118335, dose to be determined |
| MAD Part 5 Placebo Cohort B | Placebo comparator | Drug: Placebo oral suspension |
| MAD Part 5 Active Cohort C | Experimental | Drug: CORT118335, dose to be determinedCORT118335, dose to be determined |
| MAD Part 5 Placebo Cohort C | Placebo comparator | Drug: Placebo oral suspension |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male subjects or non-pregnant, non-lactating healthy female subjects of non-childbearing potential
- Age 18 to 60 years
- Body mass index (BMI) of 18.0 to 30.0 kg/m2
- Weight of ≤102 kg
- Must be willing and able to communicate and participate in the whole study
Key exclusion criteria (36 listed)
- Subjects who have received any IMP in a clinical research study within the 3 months before the first dose in this study
- Subjects who are study site or Sponsor employees, or immediate family members of a study site or Sponsor employee
- Subjects who have previously been enrolled in this study
- Males who have a pregnant partner
- History of any drug or alcohol abuse in the year before the first dose in this study
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 |
|---|---|---|
| CORT118335, 25 mgCORT118335 is supplied as capsules for oral dosing | Drug | SAD Part 1 Active Cohort A |
| Prednisone Oral TabletChallenge Agent, Dose and Route of Administration: Standard release 1x20mg and 1x5mg (25mg total) dose, orally administered. | Drug | SAD Part 2 Active PD Effect Cohort B: 630mg of CORT118335, SAD Part 2 Active PD Effect Cohort B: 675mg of CORT118335, SAD Part 2 Placebo PD Effect Cohort B |
| Glucose75 g in 300 mL solution, orally administered | Drug | SAD Part 2 Active PD Effect Cohort B: 630mg of CORT118335, SAD Part 2 Active PD Effect Cohort B: 675mg of CORT118335, SAD Part 2 Placebo PD Effect Cohort B |
| Placebo oral suspensionReference Therapy, Dose and Route of Administration: Placebo suspension, orally administered. | Drug | MAD Part 5 Placebo Cohort A, MAD Part 5 Placebo Cohort B, MAD Part 5 Placebo Cohort C, SAD Part 4 Placebo Cohort A, SAD Part 4 Placebo Cohort B, SAD Part 4 Placebo Cohort C, Fasting, SAD Part 4 Placebo Cohort C, Fed, SAD Part 4 Placebo Cohort D |
| CORT118335, 75mgCORT118335 is supplied as capsules for oral dosing | Drug | SAD Part 1 Active Cohort B |
| CORT118335, 225mgCORT118335 is supplied as capsules for oral dosing | Drug | SAD Part 1 Active Cohort C |
| CORT118335, 675mgCORT118335 is supplied as capsules for oral dosing | Drug | SAD Part 1 Active Cohort D, SAD Part 2 Active PD Effect Cohort B: 675mg of CORT118335 |
| CORT118335, 600mgCORT118335 is supplied as capsules for oral dosing | Drug | SAD Part 2 Active Cohort A, Fasting, SAD Part 2 Active Cohort A, Fed |
| CORT118335, 630mgCORT118335 is supplied as capsules for oral dosing | Drug | SAD Part 2 Active PD Effect Cohort B: 630mg of CORT118335 |
| CORT118335, 375mgCORT118335 is supplied as capsules for oral dosing | Drug | MAD Part 3 Active Cohort A |
| CORT118335, 100mgCORT118335 is supplied as a suspension for oral dosing | Drug | SAD Part 4 Active Cohort A |
| CORT118335, 300mgCORT118335 is supplied as a suspension for oral dosing | Drug | SAD Part 4 Active Cohort B |
| CORT118335, 900mgCORT118335 is supplied as a suspension for oral dosing | Drug | SAD Part 4 Active Cohort C, Fasting, SAD Part 4 Active Cohort C, Fed |
| CORT118335, 150mgCORT118335 is supplied as a suspension for oral dosing | Drug | MAD Part 5 Active Cohort A |
| CORT118335, 1500mgCORT118335 is supplied as a suspension for oral dosing | Drug | SAD Part 4 Active Cohort Part D |
| Placebo oral capsulePlacebo capsules, orally administered | Drug | MAD Part 3 Placebo Cohort A, SAD Part 1 Placebo Cohort B, SAD Part 1 Placebo Cohort C, SAD Part 1 Placebo Cohort D, SAD Part 1 Placebo oral capsule Cohort A, SAD Part 2 Placebo PD Effect Cohort B |
| CORT118335, dose to be determinedCORT118335 is supplied as suspension for oral dosing | Drug | MAD Part 5 Active Cohort B, MAD Part 5 Active Cohort C |
Primary outcome
Adverse Events (AEs)
Time frame: SAD Cohorts: Day -28 to Day 7; Part 2A Cohorts: Day -28 to Day 14; Part 2B Cohorts: Day -28 to Day 21; MAD Cohorts: Day -28 to Day 21
21 secondary outcomes
QT interval corrected for heart rate using Fridericia's formula (QTcF) exposure-response analysis
Time frame: SAD parts: Pre dose through 24 hours post dose. MAD parts: Pre first dose through 24 hours post final dose of Investigational Medicinal Product (IMP
tlag Pharmacokinetic (PK) parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
tmax PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
Cmax PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
tmin (MAD only) PK parameter
Time frame: MAD parts: Pre first dose through 96 hours post final dose of IMP
Cmin (MAD only) PK parameter
Time frame: MAD parts: Pre first dose through 96 hours post final dose of IMP
Clast PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
tlast PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
t1/2 PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
lambda-z PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
AUCinf PK parameter
Time frame: SAD parts: Pre dose through 96h post dose; MAD parts: Pre first dose through 96h post final dose of IMP
AUC(0-last) PK parameter
Time frame: SAD parts: Pre dose through 96 hours post dose; MAD parts: Pre first dose through 96 hours post final dose of IMP
AUC(0-24) PK parameter
Time frame: SAD parts: Pre dose through 24 hours post dose; MAD parts: Pre first dose through 24 hours post final dose of IMP
Food effect: AUC(0-last) PK parameter
Time frame: Pre first dose through 96 hours post final dose
Food effect: AUC(0-inf) PK parameter
Time frame: Pre first dose through 96 hours post final dose
Food effect: Cmax PK parameter
Time frame: Pre first dose through 96 hours post final dose
Pharmacodynamics (PD): peripheral differential white blood cell count
Time frame: Pre first dose through 24 hours post final dose
PD: serum osteocalcin and adiponectin concentrations
Time frame: Pre first dose through 24 hours post final dose
PD: messenger ribonucleic acid (mRNA) expression for selected genes in whole blood
Time frame: Pre first dose through 24 hours post final dose
PD: glucose tolerance
Time frame: Pre first dose through 24 hours post final dose
Homeostatic model assessment of insulin-resistance (HOMA-IR)
Time frame: Pre-dose through Day 14
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 24 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Stuart Mair, MBChB, MFPM principal investigator
Quotient Clinical
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 CORT118335, 25 mg, Prednisone Oral Tablet and Glucose in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.
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 9 inclusion and 36 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 24 May 2019. 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 United Kingdom. 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?
Adverse Events (AEs) (time frame: SAD Cohorts: Day -28 to Day 7; Part 2A Cohorts: Day -28 to Day 14; Part 2B Cohorts: Day -28 to Day 21; MAD Cohorts: Day -28 to Day 21). 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 24 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.