CORT125134 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Cortisone; Cortisone acetate; Mifepristone; Prednisone

Criteria

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