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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01495910
Other study ID # CR100007
Secondary ID 212082HPL1002
Status Completed
Phase Phase 1
First received November 23, 2011
Last updated February 27, 2014
Start date December 2011
Est. completion date February 2013

Study information

Verified date February 2014
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Abiraterone acetate
Abiraterone acetate oral suspension administered daily from study Day 1 to study Day 6 of each treatment period: the first dose level is 100 mg with escalating doses of 250 mg and 500 mg in subsequent treatment periods.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The minimum dose of abiraterone acetate required to decrease serum androstenedione to the age-appropriate range for adult women with 21-hydroxylase deficiency Normalization or reduction of age-appropriate androstenedione levels will be determined by the mean of the androstenedione values measured on Study Days 6 and 7 of the treatment period. Up to Day 7 of each treatment period. No
Secondary Mean serum concentrations of androstenedione Up to Day 8 of each treatment period. No
Secondary Mean serum concentrations of 17-hydroxyprogesterone Up to Day 8 of each treatment period. No
Secondary Mean plasma concentrations of renin activity Up to Day 8 of each treatment period. No
Secondary Mean serum concentrations of testosterone Up to Day 8 of each treatment period. No
Secondary Urine concentrations of androsterone Up to Day 8 of each treatment period. No
Secondary Urine concentrations of etiocholanolone Up to Day 8 of each treatment period. No
Secondary Maximum plasma concentration (Cmax) of abiraterone Up to Day 8 of each treatment period. No
Secondary Time to reach the maximum plasma concentration (tmax) of abiraterone Up to Day 8 of each treatment period. No
Secondary Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC24) of abiraterone Up to Day 8 of each treatment period. No
Secondary Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUClast) of abiraterone Up to Day 8 of each treatment period. No
Secondary Time to last quantifiable plasma concentration (Tlast) of abiraterone Up to Day 8 of each treatment period. No
Secondary Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone Up to Day 8 of each treatment period. No
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