Healthy
Conditions
Brief summary
This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.
Detailed description
This study will evaluate relative bioavailability of Kinetisol and spray dried dispersion (SDD) miricorilant (CORT118335) tablets. This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess the impact of fasted conditions.
Interventions
DRUGMiricorilant Treatment A
Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration
DRUGMiricorilant Treatment B
Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration
DRUGMiricorilant Treatment C
Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration
DRUGMiricorilant Treatment D
Miricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete.
Sponsors
Corcept Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to understand written informed consent * Willing and able to comply with study requirements * Willing to comply with protocol-specified contraception requirements * Healthy male or non-pregnant, non-lactating female of non-childbearing potential per Investigator assessment. * Body mass index (BMI) of 18.0 to 30.0 kg/m\^2 at screening * Weight of at least 50 kg at screening
Exclusion criteria
* Serious adverse reaction or hypersensitivity to any drug or formulation excipients * History of clinically significant allergy requiring treatment * History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder * Any form of cancer within the 5 years before the first does of this study * History and/or symptoms of adrenal insufficiency * History of clinically significant GI disease * Condition or history of a condition that could be aggravated by glucocorticoid antagonism or glucocorticoid activation * History of additional risk factors for torsades de pointes * Poor venous access that limits phlebotomy * Clinically significant abnormal clinical chemistry, hematology or urinalysis * History or evidence of hypokalemia * Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results * Evidence of renal impairment at screening * Positive serum or highly sensitive urine pregnancy test at screening or first admission * Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline * Received any investigational medicinal products (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose * Donation of blood within 2 months or donation of plasma within 1 week prior to first dose of study medication * Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies in the 14 days before first IMP administration * Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months before first IMP administration or 3 months for inhaled products * History of any drug or alcohol abuse in the past 2 years * Regular alcohol consumption as defined in the study protocol * A confirmed positive alcohol urine test at screening or first admission * Current smokers and those who have smoked within the last 12 months * Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months * A confirmed positive urine cotinine test at screening or first admission * Positive drug screen test result at screening or first admission * Male subjects with pregnant or lactating partners * Study site or Sponsor employee or immediate family members one * Failure to satisfy the Investigator of fitness to participate for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of Maximum Observed Concentration (Tmax) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose |
| Maximum Observed Concentration (Cmax) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose |
| Concentration at 24 Hours Postdose (C24) of Miricorilant | Predose and at serial timepoints up to 24 hours postdose |
| Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose |
| Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose |
| Terminal Elimination Half-Life (T1/2) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose |
| Relative Bioavailability (Frel) for Miricorilant Based on Cmax | Predose and at serial timepoints up to 72 hours postdose |
| Frel for Miricorilant based on AUC(0-last) | Predose and at serial timepoints up to 72 hours postdose |
| Frel for Miricorilant Based on AUC(0-inf) | Predose and at serial timepoints up to 72 hours postdose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings | Day -1 and 72 hours postdose in periods 3 and 4 | Clinical laboratory findings include hematology, clinical chemistry, urinalysis. |
| Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings | Day -1, predose, and at 4 and 72 hours postdose in every study period | — |
| Number of Participants with Abnormal, Clinically Significant Vital Sign Findings | Day -1, predose, and at serial time points up to 72 hours postdose in every study period | — |
| Number of Participants with Abnormal, Clinically Significant Physical Exam Findings | 72 hours postdose in periods 3 and 4 | — |
| Number of Participants with 1 or More Adverse Events | Screening up to 30 days postdose | — |
Countries
United States
Contacts
STUDY_DIRECTORJoseph Custodio, PhD
Corcept Therapeutics
Outcome results
None listed