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Healthy AdultsPhase 1NCT04994743

Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants

A Phase 1 study testing CORT113176 in people with Healthy Adults, run by Corcept Therapeutics at 1 site in Netherlands.

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

This is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Adults
What is being tested?
CORT113176
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteNetherlands
Study dates
13 Jul 2021to 30 Sep 2021
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive
  • Body weight ≤100 kg.
  • Must agree to adhere to the requirements on contraception, exposure to sexual partners, and sperm donation as defined in the protocol
  • Additional criteria apply.

Who cannot join

  • Received any investigational drug in a clinical research study within the last 90 days
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within past 5 years.
  • Regular alcohol consumption
  • Positive drug, nicotine (cotinine), or alcohol screen
  • Current smokers, user of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months
  • Have a pregnant partner
Show all 22Show fewer
  • Clinically significant abnormal clinical chemistry, hematology (including coagulation), or urinalysis
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) results
  • Positive nasopharyngeal polymerase chain reaction (PCR) test for severe acute respiratory syndrome Covid Virus-2 (SARS-CoV-2) on Day -1 or within 8 weeks prior to screening.
  • Contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose
  • Active renal and/or hepatic disease
  • History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological, or psychiatric disorder
  • Abnormalities in brain and lumbar spine, or other medical or surgical conditions or clinically significant abnormal findings, for which lumbar puncture is contraindicated
  • History of clinically significant back pain, back pathology and/or back injury
  • History of significant active bleeding or coagulation disorder or have taken non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar puncture
  • Allergy to lidocaine (Xylocaine®) or its derivatives
  • Any form of cancer within the 5 years (exceptions apply)
  • History and/or symptoms of adrenal insufficiency
  • Have a condition that could be aggravated by glucocorticoid antagonism
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • 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.

Netherlands1 site

  • Site 01

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: Multiple Dose Safety, Tolerability, Plasma and Cerebrospinal-Fluid Pharmacokinetic Study of Oral Doses of CORT113176

This is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions. Progression from Cohort 1 to Cohort 2 will be done based on the safety and tolerability outcome in Cohort 1 and after Cohort 1 has received the study drug for at least 7 days. The optional Cohort 3 may receive a higher dose that will not exceed CORT113176 450 mg once daily by mouth for 14 days under fed conditions. The progression from Cohort 2 to the optional cohort (Cohort 3) will be based on the same precautions as with the progression from Cohort 1 to Cohort 2. Each participant will undergo safety evaluations. Pharmacokinetics of CORT113176 will be assessed in plasma and cerebrospinal fluid (CSF) samples. Pharmacodynamic assessments will include the measurement of serum cortisol.

Conditions
Healthy Adults
Being tested
CORT113176, Placebo matching CORT113176

What participants receive

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

  • CORT113176Drug

    CORT113176 lipid capsule formulation for oral administration

  • Placebo matching CORT113176Drug

    Placebo matching CORT113176 lipid capsule formulation for oral administration

Study groups in NCT04994743
Study groupRoleWhat they receive
Cohort 1: CORT113176 150 mgExperimentalParticipants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days.
Receives: Drug: CORT113176
Cohort 1: Placebo matching CORT113176Placebo comparatorParticipants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.
Receives: Drug: Placebo matching CORT113176
Cohort 2: CORT113176 300 mgExperimentalParticipants will receive CORT113176 300 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Progression from Cohort 1 to 2 will be done based on safety and tolerability outcome from Cohort 1 and only after Cohort 1 has received study drug for ≥7 days.
Receives: Drug: CORT113176
Cohort 2: Placebo matching CORT113176Placebo comparatorParticipants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.
Receives: Drug: Placebo matching CORT113176
Cohort 3: CORT113176 ≥300 mgExperimentalParticipants will receive CORT113176 ≥300 mg not to exceed 450 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Cohort 3 is optional, and progression from Cohort 2 to 3 be done based on safety and tolerability outcome from Cohort 2 and only after Cohort 2 has received study drug for ≥7 days.
Receives: Drug: CORT113176
Cohort 3: Placebo matching CORT113176Placebo comparatorParticipants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.
Receives: Drug: Placebo matching CORT113176

What is being measured

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

  1. Number of Participants with One or More Adverse Events

    Measured: Up to Day 28

Secondary outcomes (6)

  1. Maximum Plasma Concentration (Cmax) of CORT113176

    Measured: Before dosing and a pre-specified time points up to Day 17

  2. Time of Cmax (Tmax) of Plasma CORT113176

    Measured: Before dosing and a pre-specified time points up to Day 17

  3. Apparent Elimination Half-life (t1/2) of Plasma CORT113176

    Measured: Before dosing and a pre-specified time points up to Day 17

  4. Area Under the Plasma Concentration-time Curve (AUC) of Plasma CORT113176

    Measured: Before dosing and a pre-specified time points up to Day 17

  5. Cerebrospinal Fluid Concentration of CORT113176

    Measured: Approximately 3 and 5 hours after dosing on Day 7

  6. Serum Concentration of Cortisol

    Measured: Before and approximately 12 hours after dosing on Days 1, 7, and 14

Timeline

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

  1. First posted6 Aug 2021
  2. Study start13 Jul 2021
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04994743
Sponsor's protocol ID
CORT113176-653
Other IDs
2021-002456-36
Status last verified
Oct 2021
First submitted
29 Jul 2021
Last updated
11 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CORT113176 in people with Healthy Adults, run by Corcept Therapeutics 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 4 inclusion and 22 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 11 Oct 2021. 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. 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 One or More Adverse Events (time frame: Up to Day 28). 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 NCT04994743.

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 11 Oct 2021.

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