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HealthyPhase 1NCT06094738

A Study to Evaluate the Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects

A Phase 1 study testing Relacorilant under fasted conditions, Relacorilant after a high-fat meal and Relacorilant after a low-fat meal in people with Healthy, run by Corcept Therapeutics at 1 site in United States.

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 primary objective of the study is to evaluate the effects of a high-fat meal and of a low-fat meal on the bioavailability of relacorilant in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Relacorilant under fasted conditions, Relacorilant after a high-fat meal and Relacorilant after a low-fat meal
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
19 Sep 2020to 16 Nov 2020
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body mass index >18.5 and <30.0 kg/m^2 and body weight ≥50.0 kg for male subjects and ≥45.0 kg for female subjects
  • Healthy, as defined by the absence of clinically significant illness and/or surgery within 4 weeks prior to dosing, and the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
  • Female subjects of childbearing potential who are sexually active with a non-sterile male partner must be willing to use an acceptable contraceptive method as defined in the protocol, throughout the study.
  • Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential must be willing to use an acceptable contraceptive method as defined in the protocol, from the first study drug administration until at least 90 days after the last study drug administration
  • Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
  • Capable of, and have given, written informed consent
  • Willing to consume a high-fat breakfast, including pork
  • Able to and willing to fast for any laboratory evaluations.

Who cannot join

  • Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C
  • Female subject with a positive pregnancy test at Screening
  • Male subject with a pregnant partner at Screening
  • Positive urine drug screen or urine cotinine test or alcohol breath test at Screening
  • History of allergic reactions to relacorilant or other related drugs, or to any excipient in the formulation
  • Clinically significant electrocardiogram abnormalities or vital sign abnormalities at Screening
Show all 15Show fewer
  • History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 83 mL of wine 12%, 200 mL of beer 5%, or 25 mL of alcohol 40%])
  • History of significant drug abuse within 1 year prior to Screening or use of soft drugs within 3 months prior to Screening or hard drugs within 1 year of Screening
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration
  • Use of medications for the timeframes specified in the protocol, with the exception of acceptable hormonal contraceptives and medications exempted by the Investigator, with agreement by the Sponsor because they are judged unlikely to affect the pharmacokinetic profile of the study drug or subject safety
  • Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing
  • Have a condition that may be aggravated by glucocorticoid antagonism (eg, asthma, any chronic inflammatory condition). 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.
  • History of malabsorption syndrome or previous gastrointestinal surgery, which could affect drug absorption or metabolism, with the exception of appendectomy and cholecystectomy
  • Pregnant or breast-feeding
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • inVentiv Health Clinical Research Services LLC

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, Single-Dose, Three-Way Crossover Study to Evaluate The Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects

The primary objective of the study is to evaluate the effects of a high-fat meal and of a low-fat meal on the bioavailability of relacorilant in healthy subjects.

Read the detailed description

Enrolled healthy male and female subjects will be randomized to receive 1 of 6 treatment sequences, each consisting of 3 treatments in 3 periods, in a crossover design. The 3 treatments will be a single oral dose of relacorilant 400 mg 1) under fasted conditions, 2) after a high-fat meal, and 3) after a low-fat meal. Each period will last 5 days, and a 7-day washout will follow Periods 1 and 2. Blood samples will be collected predose and at serial timepoints up to 4 days (Day 5) after dosing in each period for evaluation of the bioavailability of relacorilant. Secondary objectives of the study will be evaluation of the bioavailability of relacorilant metabolites, and evaluation of safety and tolerability of relacorilant when administered to healthy subjects under fasted and fed conditions.

Conditions
Healthy
Being tested
Relacorilant under fasted conditions, Relacorilant after a high-fat meal, Relacorilant after a low-fat meal

What participants receive

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

  • Relacorilant under fasted conditionsDrug

    Also called CORT125134

    Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions

  • Relacorilant after a high-fat mealDrug

    Also called CORT125134

    Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal

  • Relacorilant after a low-fat mealDrug

    Also called CORT125134

    Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal

Study groups in NCT06094738
Study groupRoleWhat they receive
Relacorilant under fasted conditionsExperimentalSubjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
Receives: Drug: Relacorilant under fasted conditions
Relacorilant after a high-fat mealExperimentalSubjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
Receives: Drug: Relacorilant after a high-fat meal
Relacorilant after a low-fat mealExperimentalSubjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
Receives: Drug: Relacorilant after a low-fat meal

What is being measured

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

  1. Area under the concentration-time curve from time zero to the last observed concentration of plasma relacorilant (AUC0-t)

    Measured: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1

  2. Area under the concentration-time curve from time zero extrapolated to infinity of plasma relacorilant (AUC0-inf)

    Measured: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1

  3. Maximal observed concentration of plasma relacorilant (Cmax)

    Measured: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1

Secondary outcomes (6)

  1. AUC0-t of relacorilant plasma metabolites

    Measured: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1

  2. AUC0-inf of relacorilant plasma metabolites

    Measured: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1

  3. Cmax of relacorilant plasma metabolites

    Measured: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1

  4. Number of subjects with one or more adverse events

    Measured: Up to Day 28

  5. Number of subjects with one or more serious adverse events

    Measured: Up to Day 55

  6. Number of subjects with one or more adverse events leading to study drug discontinuation

    Measured: Up to Day 25

Timeline

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

  1. First posted23 Oct 2023
  2. Study start19 Sep 2020
  3. Primary completion16 Nov 2020
  4. Study completion16 Nov 2020

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094738
Sponsor's protocol ID
CORT125134-129
Status last verified
Oct 2023
First submitted
17 Oct 2023
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Relacorilant under fasted conditions, Relacorilant after a high-fat meal and Relacorilant after a low-fat meal in people with Healthy, run by Corcept Therapeutics at 1 site in United States.

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 8 inclusion and 15 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 23 Oct 2023. 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 States. 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?

Area under the concentration-time curve from time zero to the last observed concentration of plasma relacorilant (AUC0-t) (time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1). 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 NCT06094738.

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 23 Oct 2023.

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