- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01495910
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
February 27, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label, Multiple-Dose, Dose-Finding Study of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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 Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States
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Michigan
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Ann Arbor, Michigan, United States
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Texas
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Dallas, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Up to Day 7 of each treatment period.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean serum concentrations of androstenedione
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Mean serum concentrations of 17-hydroxyprogesterone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Mean plasma concentrations of renin activity
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Mean serum concentrations of testosterone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Urine concentrations of androsterone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Urine concentrations of etiocholanolone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Maximum plasma concentration (Cmax) of abiraterone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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Time to reach the maximum plasma concentration (tmax) of abiraterone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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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.
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Up to Day 8 of each treatment period.
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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.
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Up to Day 8 of each treatment period.
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Time to last quantifiable plasma concentration (Tlast) of abiraterone
Time Frame: Up to Day 8 of each treatment period.
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Up to Day 8 of each treatment period.
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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.
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Up to Day 8 of each treatment period.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ACTUAL)
February 1, 2013
Study Completion (ACTUAL)
February 1, 2013
Study Registration Dates
First Submitted
November 23, 2011
First Submitted That Met QC Criteria
December 16, 2011
First Posted (ESTIMATE)
December 20, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 28, 2014
Last Update Submitted That Met QC Criteria
February 27, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Adrenal Gland Diseases
- Steroid Metabolism, Inborn Errors
- Adrenal Hyperplasia, Congenital
- Adrenogenital Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Abiraterone Acetate
Other Study ID Numbers
- CR100007
- 212082HPL1002 (OTHER: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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