A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01495910
• Date of registration: 23/11/2011
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
• Scientific title: An Open-Label, Multiple-Dose, Dose-Finding Study of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
• Date of first enrolment: December 2011
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01495910
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Premenopausal women >=18 years of age.

- Must be receiving a hormonal contraceptive agent containing both estrogen and
progesterone.

- Confirmed 21-hydroxylase deficiency by CYP21A2 genotype associated with classic
congenital adrenal hyperplasia.

- Demonstrates a >=1.5 X ULN of morning serum androstenedione concentration while
taking study-defined doses of hydrocortisone and fludrocortisone.

- No coexisting medical conditions in the opinion of the investigator that would
preclude participation in the study.

Exclusion Criteria:

- Current or history of active or chronic hepatitis, including symptomatic viral
hepatitis A, B, or C.

- Any active infection.

- Evidence of active malignancy.

- Serious or uncontrolled co-existent non-malignant disease.

- Receiving systemic glucocorticoids for any reason other than for the treatment of
21-hydroxylase deficiency.

- Any disorders that require treatment with anticonvulsants.

- Patients of child-bearing potential who are not willing to use a method of birth
control during the study and for 3 months after the end-of-study.

- Women who are pregnant or breast-feeding.

- Genotypes associated with non-classic congenital adrenal hyperplasia.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

21-hydroxylase Deficiency

Intervention(s)

Drug: Abiraterone acetate

Primary Outcome(s)

The minimum dose of abiraterone acetate required to decrease serum androstenedione to the age-appropriate range for adult women with 21-hydroxylase deficiency [Time Frame: Up to Day 7 of each treatment period.]

Secondary Outcome(s)

Mean serum concentrations of androstenedione [Time Frame: Up to Day 8 of each treatment period.]

Urine concentrations of androsterone [Time Frame: Up to Day 8 of each treatment period.]

Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC24) of abiraterone [Time Frame: Up to Day 8 of each treatment period.]

Mean plasma concentrations of renin activity [Time Frame: Up to Day 8 of each treatment period.]

Mean serum concentrations of testosterone [Time Frame: Up to Day 8 of each treatment period.]

Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUClast) of abiraterone [Time Frame: Up to Day 8 of each treatment period.]

Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone [Time Frame: Up to Day 8 of each treatment period.]

Time to reach the maximum plasma concentration (tmax) of abiraterone [Time Frame: Up to Day 8 of each treatment period.]

Maximum plasma concentration (Cmax) of abiraterone [Time Frame: Up to Day 8 of each treatment period.]

Time to last quantifiable plasma concentration (Tlast) of abiraterone [Time Frame: Up to Day 8 of each treatment period.]

Urine concentrations of etiocholanolone [Time Frame: Up to Day 8 of each treatment period.]

Mean serum concentrations of 17-hydroxyprogesterone [Time Frame: Up to Day 8 of each treatment period.]

Secondary ID(s)

212082HPL1002

CR100007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors