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Clinical Trial Summary

The purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase deficiency.


Clinical Trial Description

This is a non-randomized (patients will not be assigned by chance to study treatments), open-label (patients will know the identity of study treatments), multiple-dose, intra-patient sequential dose-escalation study with a planned enrollment of approximately 10 patients. This study will consist of a screening period and a treatment period. Due to the intra-patient dose escalation, there will be multiple treatment periods consisting of 8 days each. A rest period of at least 7 days will separate each treatment period. Eligible patients will take study-defined replacement doses of hydrocortisone and fludrocortisone. Abiraterone acetate oral suspension will be administered in daily escalating doses from 100 mg to 500 mg. Patients will proceed to the next higher dose level when the majority of the treated patients have a reduction in the androstenedione level. Serial pharmacokinetic (study of what the body does to a drug) and pharmacodynamic (study of the effects of a drug on the body) samples will be collected at each treatment period as detailed in the protocol. All patients who receive at least 1 dose of abiraterone acetate will be analyzed for safety. ;


Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01495910
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Completed
Phase Phase 1
Start date December 2011
Completion date February 2013

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01862380 - Adrenocortical Functions in Women With Nonclassical 21-hydroxylase Deficiency. N/A
Completed NCT00519818 - Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia Phase 1/Phase 2
Completed NCT00542841 - Examining Genetic Differences Among People With 21-Hydroxylase Deficiency N/A