A Study to Evaluate the Pharmacokinetics of the CORT125134 Phase 2 Formulation in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

A study designed to characterize the pharmacokinetic (PK) profile of CORT125134 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.

Key facts

Study ID

NCT06094712

Run by

Corcept Therapeutics

People needed

8

Starts

2016-04-07

Expected to finish

2016-04-27

Last updated by the study team

2023-10-23

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Body mass index between 18 kg/m\^2 to 30 kg/m\^2, inclusive, and body weight of ≥50 kg (110 pounds)
• Able to understand the study procedures, voluntarily consent to participate in this study, and provide written informed consent prior to start of any study-specific procedures
• Willing and able to remain in the study unit for the duration of the confinement period
• Must agree to use an adequate method of contraception as described in the protocol
• Must agree to study restrictions as defined in the protocol.

You may not qualify if…

• Subject and/or any of his immediate family members are employed by the study clinic, Corcept, or any subcontractor involved in this study
• Has a pregnant partner
• Has previously been enrolled in this study
• History of, and/or has been treated for, alcoholism, substance abuse, or drug abuse within the year prior to Day 1
• Positive screen for drugs of abuse or a positive alcohol result
• Current smokers and those who have smoked and/or used tobacco and/or nicotine containing products within the 6 months before Day 1 and are unable to refrain from using tobacco during the study treatment and evaluation period
• Clinically significant abnormality, in the Investigator's opinion, as indicated by the results of hematology, biochemistry, or urinalysis tests or from medical history, social history, vital signs, or physical examination
• Positive serology result for hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (HCV Ab) or HIV
• Current or past history of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, gastrointestinal or neurological disease
• Active renal and/or hepatic disease
• Any form of cancer within the 2 years prior to study entry, with the exception of basal cell and/or squamous cell cancer of the skin that has been resected completely and is without evidence of local recurrence or metastasis
• History and/or symptoms of adrenal insufficiency
• History of jaundice and/or subject has had a cholecystectomy
• Active acute or chronic infectious diseases
• History of clinically significant gastrointestinal disease including gastroesophageal reflux disease, malabsorption syndrome, colon cancer, chronic colitis, Crohn's disease, inflammatory bowel disease, gastroparesis, constipation, chronic diarrhea, obstruction, gastrointestinal bleeding, and/or ulcers
• A condition such as asthma, chronic obstructive pulmonary disease, or a chronic inflammatory condition that could be aggravated by glucocorticoid (GC) blockade
• A QTcF interval of >450 msec (at Screening and/or Day -1)
• History of additional risk factors for torsade's de pointes (eg heart failure, hypokalemia, family history of long QT syndrome)
• Heart rate at rest of <45 bpm or >100 bpm (at Screening and/or Day -1)
• Sustained sitting systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg at Screening or Day -1
• Presence or history of clinically significant allergy that requires treatment; hay fever is allowed unless it is active
• Donation of blood or blood products (including plasma) during the 8 weeks before Day 1
• Has taken any prescribed and/or over-the-counter medication for which 5 times the medication's elimination half life will not be completed by Day 1, and/or herbal preparation in the 14 days before Study Day 1. Acetaminophen (up to 1 g per day) is permitted.
• Subjects who are taking a cytochrome P450 (CYP) 3A inducer (including herbal preparations such as St John's Wort), or have taken such treatment within 1 month before Day 1
• Are currently using GCs or have a history of GC use at any dose within the last 3 months or have a history of intraarticular GC within the last 6 months

Where it is running

• Jasper Clinic — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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