HealthyPhase 1NCT04672512

Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants

A Phase 1 study testing CORT125329 lipid capsule formulation and Prednisone in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.

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

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy participants. 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?: CORT125329 lipid capsule formulation and Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 115 participants
Where: 1 siteUnited Kingdom
Study dates: 23 Oct 2020to 17 Jan 2022
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

Body mass index of 18.0 to 30.0 kg/m^2
Weight of ≤102 kg
Must agree to adhere to the contraception requirements
Additional criteria apply.

Who cannot join

Received any investigational medicinal product in a clinical research study within the 90 days
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption
Current smokers and those who have smoked within the last 6 months
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative pregnancy test at screening and admission)

Show all 21Show fewer

Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator
Confirmed positive drugs of abuse test result
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Active renal and/or hepatic disease
History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, GI, neurological or psychiatric disorder, as judged by the Investigator
Any form of cancer within the last 5 years (exceptions apply)
History and/or symptoms of adrenal insufficiency
History of clinically significant gastrointestinal disease
Has a condition that could be aggravated by glucocorticoid antagonism
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of clinically significant allergy requiring treatment
Donation or loss of greater than 400 mL of blood or plasma within the previous 3 months
Are taking, or have taken, any prescribed, over-the-counter drug (other than 4 g per day paracetamol), vitamins or herbal remedies within 14 days before the study (exceptions may apply on a case by case basis)
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
Additional criteria apply.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125329 in Healthy Subjects, With an Optional Pharmacological Effects Cohort

Read the detailed description

This is a 3-part, single-center study of single and multiple ascending doses of CORT125329 in healthy participants.

Part 1 will be a double-blind, randomized, placebo-controlled assessment of single ascending doses (SAD) of CORT125329 lipid capsule formulations. Participants will be enrolled sequentially into 1 of up to 8 cohorts, each containing 8 participants.

Part 2 will be double-blind, randomized, placebo-controlled assessments of multiple oral ascending doses (MAD) of CORT125329 lipid capsule formulations. Participants will be enrolled sequentially into 1 of up to 4 cohorts, each containing 8 participants.

Optional Part 3 will be an open-label, 2-way fixed sequence cross-over study and will serve as proof of PD (glucocorticoid receptor modulation) for CORT125329 lipid capsule formulations. Participants will be enrolled in a single cohort of 10 participants.

Throughout the study, routine safety tests will be performed. In selected parts of the study, assessments of PK (CORT125329), changes in serum cortisol and plasma adrenocorticotrophic hormone (ACTH), and changes in hematological and bone biomarkers will be measured.

Conditions: Healthy
Being tested: CORT125329 lipid capsule formulation, Placebo, Prednisone

What participants receive

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

CORT125329 lipid capsule formulationDrug
CORT125329 lipid capsule formulation 1 or 2 for oral administration
PlaceboDrug
Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration
PrednisoneDrug
Prednisone tablet for oral administration

Study groups in NCT04672512
Study group	Role	What they receive
SAD Cohort A CORT125329	Experimental	Participants will receive a single dose of CORT125329 30 mg lipid capsule formulation 1 in the fasted state on Day 1 Receives: Drug: CORT125329 lipid capsule formulation
SAD Cohort B CORT125329	Experimental	Participants will receive a single dose of CORT125329 lipid capsule formulation 1 in the fasted state on Day 1. The dose will be determined after review of safety, tolerability, and PK data from SAD Cohort A. Receives: Drug: CORT125329 lipid capsule formulation
SAD Cohorts C through H CORT125329	Experimental	Participants will receive a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts. Receives: Drug: CORT125329 lipid capsule formulation
SAD Cohorts A through H Placebo	Placebo comparator	Participants will receive a single dose of placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each placebo cohort will match that used in the corresponding CORT125329 cohort. Receives: Drug: Placebo
MAD Cohorts A through D CORT125329	Experimental	Participants will receive CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency (once- or twice-daily), formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts. Receives: Drug: CORT125329 lipid capsule formulation
MAD Cohorts A through D Placebo	Placebo comparator	Participants will receive placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency, formulation, and prandial state for each cohort will match that used in the corresponding CORT125329 cohort. Receives: Drug: Placebo
Pharmacodynamic (PD) Effect Cohort	Experimental	Participants will receive a single dose of prednisone 25 mg in the fasted or fed state on Day 1 of Period 1. The prandial state for the Period 1 treatment will be determined after review of safety and tolerability data from the SAD Cohorts. After a 7-day washout period, participants will receive a single dose of prednisone 25 mg and a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 of Period 2. The formulation and dose level of CORT125329 treatment in Period 2 will be determined after review of safety, tolerability, and PK data from the SAD cohorts. The prandial state for treatment in Period 2 will be the same used in Period 1. Receives: Drug: CORT125329 lipid capsule formulation; Drug: Prednisone

What is being measured

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

Percentage of Participants with One or More Adverse Events
Measured: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2
Percentage of Participants with One or More Serious Adverse Events
Measured: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2
Percentage of Participants Discontinued from the Study Due to an Adverse Event
Measured: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2

Secondary outcomes (13)

Plasma Pharmacokinetics (PK) of CORT125329: Maximum Observed Concentration (Cmax)
Measured: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)
Measured: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Time from Dosing at which Cmax was Apparent (Tmax)
Measured: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Apparent Elimination Half-life (t1/2)
Measured: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Area Under the Curve from Zero Time to the Last Measurable Concentration (AUC0-last)
Measured: SAD Cohorts: before dosing and at prespecified time points up to Day 11; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Area Under the Curve During a Dosing Interval (AUC0-tau)
Measured: MAD Cohorts: before dosing and at prespecified time points up to Day 15
Plasma PK of CORT125329: Area Under the Curve from Zero Time Extrapolated to Infinity (AUC0-inf)
Measured: SAD Cohorts: before dosing and at prespecified time points up to Day 11; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Serum Cortisol
Measured: MAD Cohorts: before dosing in the morning of Days 1 and 14 and in the evening of Days -1 and 14
Plasma Adrenocorticotrophic Hormone (ACTH)
Measured: MAD Cohorts: two samples taken before dosing in the morning of Days 1 and 14 and in the evening of Days -1 and 14
Eosinophil Count
Measured: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2
Lymphocyte Count
Measured: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2
Neutrophil Count
Measured: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2
Serum Osteocalcin
Measured: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2

Timeline

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

23 Oct 202017 Jan 2022

First posted17 Dec 2020
Study start23 Oct 2020
Primary completion17 Jan 2022
Study completion17 Jan 2022

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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04672512
Sponsor's protocol ID: CORT125329-140
Other IDs: 2020-001741-38
Status last verified: Feb 2022
First submitted: 14 Dec 2020
Last updated: 9 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125329 in Healthy Subjects, With an Optional Pharmacological Effects Cohort
ClinicalTrials.gov ID: NCT04672512
Acronym / sponsor ID: CORT125329-140
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Corcept TherapeuticsIndustry (pharma, biotech, devices)
Study start: 23 Oct 2020 (actual)
Primary completion: 17 Jan 2022 (actual)
Study completion: 17 Jan 2022 (actual)
First posted: 17 Dec 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.

Detailed description

This is a 3-part, single-center study of single and multiple ascending doses of CORT125329 in healthy participants.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
SAD Cohort A CORT125329	Experimental	Drug: CORT125329 lipid capsule formulationParticipants will receive a single dose of CORT125329 30 mg lipid capsule formulation 1 in the fasted state on Day 1
SAD Cohort B CORT125329	Experimental	Drug: CORT125329 lipid capsule formulationParticipants will receive a single dose of CORT125329 lipid capsule formulation 1 in the fasted state on Day 1. The dose will be determined after review of safety, tolerability, and PK data from SAD Cohort A.
SAD Cohorts C through H CORT125329	Experimental	Drug: CORT125329 lipid capsule formulationParticipants will receive a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts.
SAD Cohorts A through H Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a single dose of placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each placebo cohort will match that used in the corresponding CORT125329 cohort.
MAD Cohorts A through D CORT125329	Experimental	Drug: CORT125329 lipid capsule formulationParticipants will receive CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency (once- or twice-daily), formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts.
MAD Cohorts A through D Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency, formulation, and prandial state for each cohort will match that used in the corresponding CORT125329 cohort.
Pharmacodynamic (PD) Effect Cohort	Experimental	Drug: CORT125329 lipid capsule formulation, Drug: PrednisoneParticipants will receive a single dose of prednisone 25 mg in the fasted or fed state on Day 1 of Period 1. The prandial state for the Period 1 treatment will be determined after review of safety and tolerability data from the SAD Cohorts. After a 7-day washout period, participants will receive a single dose of prednisone 25 mg and a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 of Period 2. The formulation and dose level of CORT125329 treatment in Period 2 will be determined after review of safety, tolerability, and PK data from the SAD cohorts. The prandial state for treatment in Period 2 will be the same used in Period 1.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Body mass index of 18.0 to 30.0 kg/m^2
Weight of ≤102 kg
Must agree to adhere to the contraception requirements
Additional criteria apply.

Key exclusion criteria (21 listed)

Received any investigational medicinal product in a clinical research study within the 90 days
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption
Current smokers and those who have smoked within the last 6 months
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months

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
CORT125329 lipid capsule formulationCORT125329 lipid capsule formulation 1 or 2 for oral administration	Drug	MAD Cohorts A through D CORT125329, Pharmacodynamic (PD) Effect Cohort, SAD Cohort A CORT125329, SAD Cohort B CORT125329, SAD Cohorts C through H CORT125329
PlaceboPlacebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration	Drug	MAD Cohorts A through D Placebo, SAD Cohorts A through H Placebo
PrednisonePrednisone tablet for oral administration	Drug	Pharmacodynamic (PD) Effect Cohort

Primary outcome

Percentage of Participants with One or More Adverse Events
Time frame: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2
Percentage of Participants with One or More Serious Adverse Events
Time frame: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2
Percentage of Participants Discontinued from the Study Due to an Adverse Event
Time frame: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2

13 secondary outcomes

Plasma Pharmacokinetics (PK) of CORT125329: Maximum Observed Concentration (Cmax)
Time frame: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)
Time frame: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Time from Dosing at which Cmax was Apparent (Tmax)
Time frame: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Apparent Elimination Half-life (t1/2)
Time frame: SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Area Under the Curve from Zero Time to the Last Measurable Concentration (AUC0-last)
Time frame: SAD Cohorts: before dosing and at prespecified time points up to Day 11; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Plasma PK of CORT125329: Area Under the Curve During a Dosing Interval (AUC0-tau)
Time frame: MAD Cohorts: before dosing and at prespecified time points up to Day 15
Plasma PK of CORT125329: Area Under the Curve from Zero Time Extrapolated to Infinity (AUC0-inf)
Time frame: SAD Cohorts: before dosing and at prespecified time points up to Day 11; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2
Serum Cortisol
Time frame: MAD Cohorts: before dosing in the morning of Days 1 and 14 and in the evening of Days -1 and 14
Plasma Adrenocorticotrophic Hormone (ACTH)
Time frame: MAD Cohorts: two samples taken before dosing in the morning of Days 1 and 14 and in the evening of Days -1 and 14
Eosinophil Count
Time frame: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2
Lymphocyte Count
Time frame: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2
Neutrophil Count
Time frame: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2
Serum Osteocalcin
Time frame: PD Effect Cohort: before dosing and at prespecified time points up to 24 hours after dosing in Period 1 and 2

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 9 Feb 2022.
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.

Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator

Quotient Sciences

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 CORT125329 lipid capsule formulation and Prednisone 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 4 inclusion and 21 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 9 Feb 2022. 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?

Percentage of Participants with One or More Adverse Events (time frame: SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2). The study lists 3 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 NCT04672512.

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 9 Feb 2022.