Healthy Clinical Trial
Official title:
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects
Verified date | August 2019 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125134 and its active metabolite CORT125201 after single and multiple ascending oral doses of CORT125134 in healthy participants.
Status | Completed |
Enrollment | 130 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Provide written informed consent - Weight <= 102 kilogram (kg); body mass index (BMI) 18-30 kg/meter squared - Morning serum cortisol in reference range - Willing and able to communicate, participate in the whole study and to abide by study restrictions including use of contraception Exclusion Criteria: - Participation in any clinical research study, received treatment with any investigational drug or device, or donated blood within the previous 3 months - Has a history of alcoholism, substance abuse, or drug abuse within 1 year; positive screen for alcohol or drugs of abuse - Current smokers, smoked and/or used tobacco and/or nicotine-containing products within 6 months, or positive screen for carbon monoxide - Females of childbearing potential, pregnant or breastfeeding, and/or with a positive pregnancy test - Has a condition that could be aggravated by glucocorticoid blockade or activation - Has clinically relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead electrocardiogram (ECG) - Has history of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, chronic respiratory, gastrointestinal or neurological disease - Has used systemic glucocorticoids within 12 months |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Quotient Clinical | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United Kingdom,
Hunt H, Donaldson K, Strem M, Zann V, Leung P, Sweet S, Connor A, Combs D, Belanoff J. Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study. Clin Pharmacol Drug Dev. 2018 May;7(4):408-421. doi: 10.1002/cpdd.389. Epub 2017 Oct 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events (AEs) (Safety and Tolerability) of CORT125134 | Single dose Cohorts 1-9 Day 1 to Day 15; MAD Cohorts 10-13 Day 1 to Day 28/Day 24 (Cohort 13) | ||
Secondary | QT internal corrected for heart rate using Fridericia's formula (QTcF) exposure-response analysis | SAD Cohorts 1-6: Pre dose through 24 hours post dose; MAD Cohorts: Pre first dose through 24 hours post final dose of Investigational Medicinal Product (IMP) | ||
Secondary | CORT125134 Pharmacokinetic (PK) of total lag time (Tlag) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125134 PK of peak plasma concentration (Cmax) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125134 PK of time to reach maximum observed concentration (Tmax) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts 10-12 Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125134 PK of area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125201 PK of peak plasma concentration (Cmax) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125201 PK time Lag (Tlag) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125201 PK of time to reach maximum observed concentration (Tmax) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13) | ||
Secondary | CORT125201 PK of area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) | Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Say 28/24 (Cohort 13) | ||
Secondary | Eosinophil count | Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15 | ||
Secondary | Lymphocyte count | Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15 | ||
Secondary | Neutrophil count | Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15 | ||
Secondary | Osteocalcin | Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15 | ||
Secondary | FKBP5 expression | Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15 | ||
Secondary | Glucocorticoid-induced leucine zipper (GILZ) expression | Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15 | ||
Secondary | Glucose tolerance | Single dose Cohort 9 Days -19 to Day 2; MAD Cohort 13 Days -5 to Day 15 | ||
Secondary | Serum cortisol | SAD Cohorts 1-6: Pre dose to Day 15; MAD Cohorts 10-11: Pre dose to Day 28 | ||
Secondary | Plasma adrenocorticotrophic hormone (ACTH) | SAD Cohorts 1-6: Pre dose to Day 15; MAD Cohorts 10-11: Pre dose to Day 28 |
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