HealthyPhase 1NCT01416870
Bioequivalence of Bicalutamide New Formulation in Japan
A Phase 1 study testing ICI176,334-1 and Casodex 80 mg tablet in people with Healthy, run by AstraZeneca.
Trial summary
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ICI176,334-1 and Casodex 80 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Nov 2010
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years
- Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 17 and 27 kg/m2
- Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)
Who cannot join
- Presence of any disease under medical treatment
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
- Presence of any infectious disease, such as bacteria, virus and fungus
- Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
- Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
About this study
Official title: Bioequivalence Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex Tablet (80mg)
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
Read the detailed description
Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)
- Conditions
- Healthy
- Being tested
- ICI176,334-1, Casodex 80 mg tablet
- Keywords
- Bioequivalence, pharmacokinetics, safety, bicalutamide, Casodex, Japanese, healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICI176,334-1Drug
Subject will receive single dose of ICI176,334-1
Casodex 80 mg tabletDrug
Subject will receive single dose of Casodex 80 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Active 1 | Experimental | 34 subjects will receive ICI176,334-1without water Receives: Drug: ICI176,334-1 |
| Active 2 | Experimental | 34 subjects will receive ICI176,334-1 with water Receives: Drug: ICI176,334-1 |
| Active 3 | Experimental | 34 subjects will receive Casodex 80 mg tablet Receives: Drug: Casodex 80 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug).
Measured: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of AUC (concentration Area Under the Curve).
Measured: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 (half time) of bicalutamide
Measured: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
Secondary outcomes (3)
To assess the safety by assessment of adverse event.
Measured: Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose.
To assess the safety by assessment of vital signs.
Measured: Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Measured: Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416870
- Sponsor's protocol ID
- D6874L00012
- Status last verified
- Jan 2012
- First submitted
- 12 Aug 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex Tablet (80mg)
- ClinicalTrials.gov ID
- NCT01416870
- Acronym / sponsor ID
- D6874L00012
- Conditions
- Healthy
- Keywords
- Bioequivalence, pharmacokinetics, safety, bicalutamide, Casodex, Japanese, healthy subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Aug 2011 (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 investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
Detailed description
Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active 1 | Experimental | Drug: ICI176,334-134 subjects will receive ICI176,334-1without water |
| Active 2 | Experimental | Drug: ICI176,334-134 subjects will receive ICI176,334-1 with water |
| Active 3 | Experimental | Drug: Casodex 80 mg tablet34 subjects will receive Casodex 80 mg tablet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years
- Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 17 and 27 kg/m2
- Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)
Key exclusion criteria (5 listed)
- Presence of any disease under medical treatment
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
- Presence of any infectious disease, such as bacteria, virus and fungus
- Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
- Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
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 |
|---|---|---|
| ICI176,334-1Subject will receive single dose of ICI176,334-1 | Drug | Active 1, Active 2 |
| Casodex 80 mg tabletSubject will receive single dose of Casodex 80 mg tablet | Drug | Active 3 |
Primary outcome
To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug).
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of AUC (concentration Area Under the Curve).
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 (half time) of bicalutamide
Time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
3 secondary outcomes
To assess the safety by assessment of adverse event.
Time frame: Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose.
To assess the safety by assessment of vital signs.
Time frame: Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Time frame: Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICI176,334-1 and Casodex 80 mg tablet in people with Healthy, run by AstraZeneca.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug). (time frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period). The study lists 3 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 11 Jan 2012.