PharmacokineticsPhase 1NCT04295161
A Study Designed to Evaluate the Pharmacokinetic Profile of Abiraterone
A Phase 1 study testing Abiraterone Acetate in people with Pharmacokinetics, run by Zentiva, k.s. at 1 site in United Kingdom.
Trial summary
A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations 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
- Pharmacokinetics
- What is being tested?
- Abiraterone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2019to 8 Nov 2019
- 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
- Healthy males
- Age 18 to 55 years of age at the time of signing informed consent
- Expressed a desire not to father children in the near future (within 6 months of last IMP dose); males under 40 years of age must have been vasectomised
- Body mass index (BMI) of 18.5 to 30.0 kg/m2 as measured at screening
- Willing and able to communicate and participate in the whole study
- Provided written informed consent
- Agreed to adhere to the contraception requirements defined in Section 9.4 of the protocol
Who cannot join
- Subjects who received any IMP in a clinical research study within the 3 months or 90 days prior to Day 1 Period 1
- Males with a pregnant female partner
- Subjects were unable or unwilling to consume the standard high-fat breakfast (Part 2)
- Subjects were study site employees, or immediate family members of a study site or sponsor employee
- Subjects who had previously been enrolled in this study. Subjects who had taken part in Part 1 were not permitted to take part in Part 2
- History of any drug or alcohol abuse in the past 2 years prior to screening
Show all 27Show fewer
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type) as confirmed by a repeat of the first positive alcohol breath test at screening or admission
- Current smokers and those who had smoked within the last 12 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm, as confirmed by repeat of the first test at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months prior to screening
- Subjects without suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator
- Serum potassium below the lower limit of the laboratory reference range at screening
- Alanine aminotransferase >1.5× upper limit of laboratory reference range at screening
- Total bilirubin >1.5× upper limit of laboratory reference range at screening
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) orhuman immunodeficiency virus (HIV) results at screening
- Systolic blood pressure (BP) >140 mmHg, diastolic blood pressure >90 mmHg (systolic blood pressure up to 150 mmHg allowed in subjects >45 years of age) at screening or Period 1 Day 1 pre-dose
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subjects with a history of cholecystectomy or gall stones
- Serious adverse reaction or serious hypersensitivity to any drug
- History of any hypersensitivity reaction to abiraterone or the formulation excipients regardless of severity
- Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, lactose intolerance
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active
- Donation or loss of greater than 400 mL of blood within the previous 3 months prior to screening
- Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other than 4 g of paracetamol per day) or herbal remedies in the 14 days before Day 1, Period 1. Exceptions may have been applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI
- Use of known strong CYP3A4 inducers, including St John's Wort, in the 30 days prior to Period 1 Day 1
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations
A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations
Read the detailed description
This was a single centre, 2 part, open-label study in healthy male subjects. Parts 1 and 2 were conducted in separate cohorts of subjects; subjects were not permitted to participate in both parts. Part 1 was a part-randomised, 4 period crossover study planned to include 24 healthy male subjects. Part 2 was a randomised 2-period crossover study in 12 healthy male subjects. The aim was to evaluate the pharmacokinetic profiles of abiraterone following administration of immediate release prototype formulations in healthy male subjects.
- Conditions
- Pharmacokinetics
- Being tested
- Abiraterone Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
Abiraterone acetate immediate release formulations
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Not described Receives: Drug: Abiraterone Acetate |
| Prototype 1 | Experimental | Not described Receives: Drug: Abiraterone Acetate |
| Prototype 2 | Experimental | Not described Receives: Drug: Abiraterone Acetate |
| Prototype 3 | Experimental | Not described Receives: Drug: Abiraterone Acetate |
| Prototype 4 fasted | Experimental | administered in fasted state Receives: Drug: Abiraterone Acetate |
| Prototype 4 fed | Experimental | Administered in fed state Receives: Drug: Abiraterone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abiraterone Cmax
maximal concentration of abiraterone in human plasma
Measured: 24h
Abiraterone AUC
total exposure up to 24h of abiraterone in human plasma
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start25 Jun 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentiva, k.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295161
- Sponsor's protocol ID
- ABIRAL00005
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations
- ClinicalTrials.gov ID
- NCT04295161
- Acronym / sponsor ID
- ABIRAL00005
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Zentiva, k.s.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 4 Mar 2020 (actual)
- 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.
A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations
Detailed description
This was a single centre, 2 part, open-label study in healthy male subjects. Parts 1 and 2 were conducted in separate cohorts of subjects; subjects were not permitted to participate in both parts. Part 1 was a part-randomised, 4 period crossover study planned to include 24 healthy male subjects. Part 2 was a randomised 2-period crossover study in 12 healthy male subjects. The aim was to evaluate the pharmacokinetic profiles of abiraterone following administration of immediate release prototype formulations in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Drug: Abiraterone Acetate |
| Prototype 1 | Experimental | Drug: Abiraterone Acetate |
| Prototype 2 | Experimental | Drug: Abiraterone Acetate |
| Prototype 3 | Experimental | Drug: Abiraterone Acetate |
| Prototype 4 fasted | Experimental | Drug: Abiraterone Acetateadministered in fasted state |
| Prototype 4 fed | Experimental | Drug: Abiraterone AcetateAdministered in fed state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males
- Age 18 to 55 years of age at the time of signing informed consent
- Expressed a desire not to father children in the near future (within 6 months of last IMP dose); males under 40 years of age must have been vasectomised
- Body mass index (BMI) of 18.5 to 30.0 kg/m2 as measured at screening
- Willing and able to communicate and participate in the whole study
Key exclusion criteria (27 listed)
- Subjects who received any IMP in a clinical research study within the 3 months or 90 days prior to Day 1 Period 1
- Males with a pregnant female partner
- Subjects were unable or unwilling to consume the standard high-fat breakfast (Part 2)
- Subjects were study site employees, or immediate family members of a study site or sponsor employee
- Subjects who had previously been enrolled in this study. Subjects who had taken part in Part 1 were not permitted to take part in Part 2
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 |
|---|---|---|
| Abiraterone AcetateAbiraterone acetate immediate release formulations | Drug | Prototype 1, Prototype 2, Prototype 3, Prototype 4 fasted, Prototype 4 fed, Reference |
Primary outcome
Abiraterone Cmax
Time frame: 24h
maximal concentration of abiraterone in human plasma
Abiraterone AUC
Time frame: 24h
total exposure up to 24h of abiraterone in human plasma
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 4 Mar 2020.
- Individual participant dataSharing planned: No
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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.
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 Abiraterone Acetate in people with Pharmacokinetics, run by Zentiva, k.s. at 1 site in United Kingdom.
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 7 inclusion and 27 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 4 Mar 2020. 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 Kingdom. 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?
Abiraterone Cmax (time frame: 24h). The study lists 2 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 4 Mar 2020.