Healthy VolunteersPhase 1NCT01897389
A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agrees to protocol-defined use of effective contraception for up to 1 week after receiving the last dose of study drug and agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug
- Body mass index between 18.5 and 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
- Blood pressure (after lying down for 5 minutes) between 90 and 140 mmHg systolic and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Non-smoker and no use of nicotine-containing substances within the previous 2 months
- Laboratory values within protocol-defined parameters
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram at screening or at admission to the study center as deemed appropriate by the investigator
- Screening serum testosterone level of <200 ng/dL
- Presence of sexual dysfunction or any medical condition that would affect sexual function
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled through study completion
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
Show all 14Show fewer
- Positive test for drugs of abuse (such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens, or barbiturates) at screening and Day -1 of each treatment period
- Known allergy to the study drug or any of the excipients of the formulation
- History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed)
- Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
- Unable to swallow solid, oral dosage forms whole with the aid of water
- Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibodies
- Preplanned surgery or procedures that would interfere with the conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, 4-Period, 5-Treatment Crossover Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects
The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.
Read the detailed description
This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 4-period, 5-treatment crossover study in order to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation. Approximately 32 healthy adult males will participate. The total study length is up to 68 days. This study will consist of a screening phase followed by an open-label treatment phase consisting of 4 single-dose treatment periods separated by a washout period of at least 7 days between dosing. Individuals will be randomly assigned to 1 of 8 treatment sequences. A single dose of 1000 mg abiraterone acetate will be given in each treatment period under fasted conditions. Participants will be confined to the study center from Day -1 of each treatment period until completion of the 96-hour blood sample collection on Day 5 of each treatment period. A follow-up visit will occur between 5 to 7 days after the last study procedure. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
- Keywords
- Healthy volunteers, Bioavailability, Abiraterone acetate, ZYTIGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions
Treatment BDrug
1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions
Treatment CDrug
1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions
Treatment DDrug
1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
Treatment EDrug
1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: abiraterone acetate | Experimental | Treatment sequence 1 is defined as: AEBD Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment D; Drug: Treatment E |
| Sequence 2: abiraterone acetate | Experimental | Treatment sequence 2 is defined as: BACE Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment E |
| Sequence 3: abiraterone acetate | Experimental | Treatment sequence 3 is defined as: CBDA Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D |
| Sequence 4: abiraterone acetate | Experimental | Treatment sequence 4 is defined as: EDAC Receives: Drug: Treatment A; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E |
| Sequence 5: abiraterone acetate | Experimental | Treatment sequence 5 is defined as: DECA Receives: Drug: Treatment A; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E |
| Sequence 6: abiraterone acetate | Experimental | Treatment sequence 6 is defined as: EADB Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment D; Drug: Treatment E |
| Sequence 7: abiraterone acetate | Experimental | Treatment sequence 7 is defined as: ABEC Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment E |
| Sequence 8: abiraterone acetate | Experimental | Treatment sequence 8 is defined as: BCAD Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of abiraterone
Measured: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone
Measured: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Measured: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Measured: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Time to reach the maximum plasma concentration of abiraterone
Measured: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Secondary outcomes (1)
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Measured: Up to 30 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897389
- Sponsor's protocol ID
- CR102353
- Other IDs
- 212082PCR1010
- Status last verified
- Nov 2014
- First submitted
- 9 Jul 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 4-Period, 5-Treatment Crossover Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01897389
- Acronym / sponsor ID
- CR102353
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Bioavailability, Abiraterone acetate, ZYTIGA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.
Detailed description
This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 4-period, 5-treatment crossover study in order to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation. Approximately 32 healthy adult males will participate. The total study length is up to 68 days. This study will consist of a screening phase followed by an open-label treatment phase consisting of 4 single-dose treatment periods separated by a washout period of at least 7 days between dosing. Individuals will be randomly assigned to 1 of 8 treatment sequences. A single dose of 1000 mg abiraterone acetate will be given in each treatment period under fasted conditions. Participants will be confined to the study center from Day -1 of each treatment period until completion of the 96-hour blood sample collection on Day 5 of each treatment period. A follow-up visit will occur between 5 to 7 days after the last study procedure. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment D, Drug: Treatment ETreatment sequence 1 is defined as: AEBD |
| Sequence 2: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment ETreatment sequence 2 is defined as: BACE |
| Sequence 3: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment DTreatment sequence 3 is defined as: CBDA |
| Sequence 4: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment C, Drug: Treatment D, Drug: Treatment ETreatment sequence 4 is defined as: EDAC |
| Sequence 5: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment C, Drug: Treatment D, Drug: Treatment ETreatment sequence 5 is defined as: DECA |
| Sequence 6: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment D, Drug: Treatment ETreatment sequence 6 is defined as: EADB |
| Sequence 7: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment ETreatment sequence 7 is defined as: ABEC |
| Sequence 8: abiraterone acetate | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment DTreatment sequence 8 is defined as: BCAD |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agrees to protocol-defined use of effective contraception for up to 1 week after receiving the last dose of study drug and agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug
- Body mass index between 18.5 and 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
- Blood pressure (after lying down for 5 minutes) between 90 and 140 mmHg systolic and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Non-smoker and no use of nicotine-containing substances within the previous 2 months
Key exclusion criteria (14 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram at screening or at admission to the study center as deemed appropriate by the investigator
- Screening serum testosterone level of <200 ng/dL
- Presence of sexual dysfunction or any medical condition that would affect sexual function
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled through study completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions | Drug | Sequence 1: abiraterone acetate, Sequence 2: abiraterone acetate, Sequence 3: abiraterone acetate, Sequence 4: abiraterone acetate, Sequence 5: abiraterone acetate, Sequence 6: abiraterone acetate, Sequence 7: abiraterone acetate, Sequence 8: abiraterone acetate |
| Treatment B1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions | Drug | Sequence 1: abiraterone acetate, Sequence 2: abiraterone acetate, Sequence 3: abiraterone acetate, Sequence 6: abiraterone acetate, Sequence 7: abiraterone acetate, Sequence 8: abiraterone acetate |
| Treatment C1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions | Drug | Sequence 2: abiraterone acetate, Sequence 3: abiraterone acetate, Sequence 4: abiraterone acetate, Sequence 5: abiraterone acetate, Sequence 7: abiraterone acetate, Sequence 8: abiraterone acetate |
| Treatment D1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions | Drug | Sequence 1: abiraterone acetate, Sequence 3: abiraterone acetate, Sequence 4: abiraterone acetate, Sequence 5: abiraterone acetate, Sequence 6: abiraterone acetate, Sequence 8: abiraterone acetate |
| Treatment E1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions | Drug | Sequence 1: abiraterone acetate, Sequence 2: abiraterone acetate, Sequence 4: abiraterone acetate, Sequence 5: abiraterone acetate, Sequence 6: abiraterone acetate, Sequence 7: abiraterone acetate |
Primary outcome
Maximum plasma concentration of abiraterone
Time frame: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone
Time frame: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time frame: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Time frame: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
Time to reach the maximum plasma concentration of abiraterone
Time frame: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h
1 secondary outcome
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Time frame: Up to 30 days after the last dose of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration of abiraterone (time frame: Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.