NCT01495910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

November 23, 2011

Last Update Submit

February 27, 2014

Conditions

21-hydroxylase Deficiency

Keywords

21-hydroxylase deficiencyAndrostenedioneAbiraterone acetatePharmacokineticsPharmacodynamicsDose-finding

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (12)

  • Mean serum concentrations of androstenedione

    Up to Day 8 of each treatment period.

  • Mean serum concentrations of 17-hydroxyprogesterone

    Up to Day 8 of each treatment period.

  • Mean plasma concentrations of renin activity

    Up to Day 8 of each treatment period.

  • Mean serum concentrations of testosterone

    Up to Day 8 of each treatment period.

  • Urine concentrations of androsterone

    Up to Day 8 of each treatment period.

  • +7 more secondary outcomes

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

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.

Drug: Abiraterone acetate

Interventions

Abiraterone acetateDRUG

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.

Abiraterone acetate

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Related Links

MeSH Terms

Conditions

Congenital adrenal hyperplasia due to 21 hydroxylase deficiency

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

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

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

December 20, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

US(3)