Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A study designed to characterize the plasma pharmacokinetic (PK) profile of CORT125134 in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134 for...
Detailed Description
Initially, subjects will be enrolled into 2 cohorts each of 8 subjects (Cohort 1 and Cohort 2) to receive CORT125134 at 150 mg or 250 mg, respectively. Data from Cohorts 1 and 2 will be evaluated to s...
Eligibility Criteria
Inclusion
- Give written informed consent
- Be healthy males or non-pregnant, non-lactating healthy females
- Must agree to use an adequate method of contraception as described in the study protocol
- Have a body mass index (BMI) of 18 to 32 kg/m\^2, inclusive and body weight more than 50 kg (110 pounds)
- Be willing to comply with study restrictions as described in study protocol
- Be able to comply with the requirements of the entire study
- Be judged to be in good health, based on the results of medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory findings
- Have suitable veins for multiple venipuncture/cannulation
Exclusion
- Be an employee or immediate family member of the Clinical Research Unit or Corcept
- Have been previously enrolled in this study
- Have multiple drug allergies, or be allergic to any of the components of study drug
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
- In the 1 year before study drug administration, have a history of drug or alcohol abuse
- In the 6 calendar months before study drug administration, on average: have smoked more than 5 cigarettes/day, consumed more than 14 units (female) or 21 units (male) of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor), consumed licorice or other glycyrrhetic acid derivatives regularly, in the judgement of the Investigator
- In the 2 calendar months before study drug administration, have donated/ lost blood or plasma in excess of 400 mL
- In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
- Have a positive test for alcohol or drugs of abuse at Screening or admission
- Have a positive test for exogenous glucocorticoids at Screening
- Have clinically-relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at Screening and/or before first dose
- Have any medical or social reasons for not participating in the study raised by their primary care physician
- Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
- Have taken any prohibited prior medication, as described in study protocol
Key Trial Info
Start Date :
May 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06094790
Start Date
May 18 2017
End Date
November 15 2017
Last Update
October 23 2023
Active Locations (1)
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1
Quotient Sciences, Miami, Inc.
Miami, Florida, United States, 33126