Metastatic Castration-resistant Prostate CancerPhase 1NCT04879589
Phase 1 Study of ATRS-2002 in Healthy Male Adults
A Phase 1 study testing Abiraterone Acetate in people with Metastatic Castration-resistant Prostate Cancer, run by Syneos Health.
Trial summary
To access the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ATRA-2002 against commercially available oral formulation of abiraterone acetate in healthy male adults 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
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Abiraterone Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 20 Apr 2023
- 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
- Voluntarily provide written informed consent for participation in the study.
- Be a male 18 to 55 years of age, inclusive at the time of consent.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening.
- Have a normal electrocardiogram (ECG) at screening.
- Have normal results for hematology, biochemistry, liver function, lipids and urinalysis tests at screening and at Day -1, as defined by laboratory normal ranges. Subjects with results outside of the normal ranges that are considered to be not of clinical significance may be admitted to the study at the discretion of the Investigator.
- Have a potassium level greater than or equal to 3.8 mEq/L.
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- Have a testosterone value within the normal range at screening.
- Have vital signs within the normal range at screening, as defined by site standard ranges. Assessments for vital signs may be repeated up to 3 times, at the discretion of the Investigator.
- Subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of child bearing potential (does not include post menopausal women [absence of menses for 12 months prior to drug administration] or women who have had a hysterectomy or bilateral oophorectomy [at least 6 months prior to drug administration]) must be willing to use one of the following acceptable contraceptive methods for at least 120 days post-dose:
- Simultaneous use of a condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks);
- Simultaneous use of a male condom and, for the female partner, intra-uterine contraceptive device (placed since at least 4 weeks).
- Subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner who have had a tubal ligation from at least 6 months prior to drug administration must be willing to use a condom for at least 120 days post-dose.
- Must be willing not to donate sperm until at least 120 days post-dose
- Be able and willing to comply with all study procedures and agree to participate in the study program as outlined in the protocol.
Who cannot join
- Has a known allergy to study drug or any excipients contained within the study drug.
- Has any acute or active chronic disease. Mild conditions that only require intermittent treatment and are unlikely to interfere with study results may be permitted at the discretion of the Investigator (examples include seasonal hay fever and mild eczema).
- Has a history of any clinically important cardiovascular, pulmonary, hepatic, renal, dermal, central nervous system (CNS), or neuromuscular disease disorders or asthma (excluding non current, childhood asthma) or diabetes or any other clinically important disorder, as determined by the Investigator.
- Has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs or any condition that may confound the PK analyses, particularly hepatic or renal disease, as determined by the Investigator.
- Has a history of anaphylaxis, or other severe reaction, to a drug, food, toxin, or other exposure.
- Has an elevated PSA level at screening.
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- Has received another investigational drug including investigational agent(s) targeting the androgen receptor within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.
- Is taking, or has taken, any prescribed or over-the-counter drug or herbal product known to modulate cytochrome P450 (CYP)17 (e.g., ketoconazole, abiraterone acetate, orteronel, galeterone, or seviteronel) in the 30 days prior to the screening visit, or is planning to take any of these medications at any time during the study.
- Is taking, or has taken, any prescribed or over-the-counter drug, herbal, or food known to modulate CYP3A4 in the 30 days prior to the screening visit, or is planning to take any of these medications or foods at any time during the study.
- Is taking, or has taken, any prescribed CYP2D6 substrate in the 7 days (or 5 half-lives, whichever is longer) prior to the screening visit, or is planning to take any of these medications or foods at any time during the study.
- Has a history of alcohol abuse (regularly drinks more than 10 units of alcohol per week; 1 unit = 375 mL of beer [3.5% ABV], 100 mL of wine [13.5% ABV], or 30 mL of spirit [40% ABV]).
- Has a positive breathalyzer test at screening or at check-in (Day -1).
- Has a history or current evidence of abuse of licit or illicit drug substances or a positive urine drug screen for drugs of abuse at screening or before dosing. Screening of illicit drug substances include: amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine (MDMA), phencyclidine (PCP), and tetrahydrocannabinol (THC).
- Currently uses tobacco-containing, e-cigarette, nicotine replacement products, or has a history of tobacco use within 3 months prior to the screening visit. Subjects must not have a lifetime history of more than the equivalent of 10 pack-years.
- Has a positive urine cotinine test at screening or at check-in (Day -1).
- Has donated blood or plasma within 90 days prior to the screening visit.
- Has a history of any psychiatric conditions, which at the discretion of the Investigator will pose a risk to the subject if they were to be exposed to the IP, or which would have the potential to compromise the outcomes of the study.
- Has a history of suicidal ideation, suicide attempts, or psychiatric hospitalizations.
- Has a positive result for Human Immunodeficiency Virus (HIV) 1/2 antibody, hepatitis C antibody, or hepatitis B surface antigen.
- Has a history of malignancy within the past 5 years before the screening visit, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin.
- Has adrenal insufficiency or has used oral or inhaled corticosteroids within the past 12 months before the screening visit. Intranasal corticosteroids may be permitted.
About this study
Official title: Phase 1, Open-Label, Single-Ascending Dose, Parallel Group Study to Determine the Pharmacokinetics, Safety, and Tolerability of ATRS-2002 Administered Subcutaneously in Healthy Adult Males
To access the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ATRA-2002 against commercially available oral formulation of abiraterone acetate in healthy male adults
Read the detailed description
The study will be conducted in 4 dosing groups of 8 subjects each.
Thirty-two healthy adult men will be randomly assigned to a treatment cohort and will receive either a single Subcutaneous (SC) dose of ATRS-2002 (abiraterone acetate), or a single oral dose of the commercially available formulation of abiraterone acetate (Zytiga®). Additionally, for Cohorts 1 through 3, a single subject will be randomized as a sentinel subject to be dosed at least 24 hours prior to the rest of cohort (ROC).
Dosing in the abiraterone acetate SC cohorts will be sequential and will start with subjects in the lowest SC dosing cohort (i.e., 25 mg). Dosing will not begin in the next highest SC dose cohort until all safety data, as well as available PK (Pharmacokinetic) data and TT levels, from the previous cohort(s) have been reviewed by the safety review committee (SRC e.g., Sponsor and Investigator) and it has been deemed safe to proceed to the next highest dose.
Dosing in the oral abiraterone acetate cohort (Cohort 4) may begin at any time during the study.
- 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
Also called Zytiga
ATRS-2002
| Study group | Role | What they receive |
|---|---|---|
| SC ATRS-2002 | Experimental | 3 different dosages [25mg (0.13mL) , 75mg (0.4mL) and 200mg (1.05mL)] will be tested as single SC injection into the abdomen. Receives: Drug: Abiraterone Acetate |
| Oral Abiraterone Acetate | Active comparator | A single dose of 1000mg of commercially available oral formulation of abiraterone acetate will be administered to enrolled participants in Cohort 4 Receives: Drug: Abiraterone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment
Peak concentration (CMAX)
Measured: Pre-dose (within 30 minutes), Post dose - 4hours, 8hours, 12hours on day 1 and then 24hours, 36hours, 48hours, 60hours, 72hours, 84hours, 96hours, 168hours, 240hours, 336hours, 504hours, 672hours
Pharmacodynamic assessment
To determine TT (total testosterone) and LH (luteinizing hormone) levels from whole blood
Measured: Pre-dose (within 30 minutes), Post dose - 4hours, 8hours, 12hours on day 1 and then 24hours, 36hours, 48hours, 60hours, 72hours, 84hours, 96hours, 168hours, 240hours, 336hours, 504hours, 672hours
Secondary outcomes (10)
Safety assessment
Normal 12-Lead ECG
Measured: Screening (Days -28 to -2), Day -1 and Days 1,3,5 and 15
Safety assessment
Abnormal Blood pressure
Measured: Screening (Days -28 to -2), Predose - 4 hours, 8 hours, 12 hours, 24hours, 36hours, 48 hours, 72 hours and 96 hours. Vital signs will also be measured on Day 8, 11, 15, 22 and 29.
Safety assessment
Abnormal Heart rate and respiratory rate
Measured: Screening (Days -28 to -2), Predose - 4 hours, 8 hours, 12 hours, 24hours, 36hours, 48 hours, 72 hours and 96 hours. Vital signs will also be measured on Day 8, 11, 15, 22 and 29.
Safety assessment
Abnormal Tympanic temperature
Measured: Screening (Days -28 to -2), Predose - 4 hours, 8 hours, 12 hours, 24hours, 36hours, 48 hours, 72 hours and 96 hours. Vital signs will also be measured on Day 8, 11, 15, 22 and 29.
Safety assessment
Abnormal Lab tests-Hematology (Hemoglobin, hematocrit, platelets, red blood cells, white blood cells and differential)
Measured: Screening (Days -28 to -2), Day -1, Day 3, Day 8, Day15 and Day 29
Safety assessment
Abnormal Lab tests-Serum Chemistry (Urea, glucose, creatinine, sodium, potassium, chloride, bicarbonate, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin, AM cortisol, lipid profile (screening only))
Measured: Screening (Days -28 to -2), Day -1 and Days 3, 5, 8, 11, 15, 22, and Day 29
Safety assessment
Abnormal Lab tests-PSA (Prostate specific antigen)
Measured: Screening (Days -28 to -2) and Day 29
Safety assessment
Abnormal Lab tests-Urinalysis (Color, clarity/turbidity, pH, specific gravity, glucose, ketones, nitrite, leukocyte esterase, microscopy)
Measured: Screening (Days -28 to -2), Day -1, Day 3, Day 5, Day 15, Day 29
Local tolerability
Inspection of injection site for local reactions including erythema, edema, blistering, peeling skin, and rash)
Measured: Pre-dose, post dose-4 hours, 8hours, 12hours, 24hours, 36hours, 48hours, 72hours and 96 hours. Inspection will also be done at FU visits on Day 8, 11,15, 22 and 29
Local tolerability
Pain intensity (11-point numeric pain rating scale (NPRS: 0-10) where 0=no pain and 10=the worst pain imaginable)
Measured: Immediately after SC dosing on day 1, 4, 8, 12, 24, 36, 48, 60, 72 and 96 hrs post dose. On day 8-to measure pain 11-point numeric pain rating scale will be used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Sep 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Why it stopped: Study abandoned, no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- Antares Pharma Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879589
- Sponsor's protocol ID
- ATRS-2002-20-001
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Single-Ascending Dose, Parallel Group Study to Determine the Pharmacokinetics, Safety, and Tolerability of ATRS-2002 Administered Subcutaneously in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT04879589
- Acronym / sponsor ID
- ATRS-2002-20-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study abandoned, no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Antares Pharma Inc.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 10 May 2021 (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.
To access the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ATRA-2002 against commercially available oral formulation of abiraterone acetate in healthy male adults
Detailed description
The study will be conducted in 4 dosing groups of 8 subjects each.
Thirty-two healthy adult men will be randomly assigned to a treatment cohort and will receive either a single Subcutaneous (SC) dose of ATRS-2002 (abiraterone acetate), or a single oral dose of the commercially available formulation of abiraterone acetate (Zytiga®). Additionally, for Cohorts 1 through 3, a single subject will be randomized as a sentinel subject to be dosed at least 24 hours prior to the rest of cohort (ROC).
Dosing in the abiraterone acetate SC cohorts will be sequential and will start with subjects in the lowest SC dosing cohort (i.e., 25 mg). Dosing will not begin in the next highest SC dose cohort until all safety data, as well as available PK (Pharmacokinetic) data and TT levels, from the previous cohort(s) have been reviewed by the safety review committee (SRC e.g., Sponsor and Investigator) and it has been deemed safe to proceed to the next highest dose.
Dosing in the oral abiraterone acetate cohort (Cohort 4) may begin at any time during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC ATRS-2002 | Experimental | Drug: Abiraterone Acetate3 different dosages [25mg (0.13mL) , 75mg (0.4mL) and 200mg (1.05mL)] will be tested as single SC injection into the abdomen. |
| Oral Abiraterone Acetate | Active comparator | Drug: Abiraterone AcetateA single dose of 1000mg of commercially available oral formulation of abiraterone acetate will be administered to enrolled participants in Cohort 4 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Voluntarily provide written informed consent for participation in the study.
- Be a male 18 to 55 years of age, inclusive at the time of consent.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening.
- Have a normal electrocardiogram (ECG) at screening.
- Have normal results for hematology, biochemistry, liver function, lipids and urinalysis tests at screening and at Day -1, as defined by laboratory normal ranges. Subjects with results outside of the normal ranges that are considered to be not of clinical significance may be admitted to the study at the discretion of the Investigator.
Key exclusion criteria (21 listed)
- Has a known allergy to study drug or any excipients contained within the study drug.
- Has any acute or active chronic disease. Mild conditions that only require intermittent treatment and are unlikely to interfere with study results may be permitted at the discretion of the Investigator (examples include seasonal hay fever and mild eczema).
- Has a history of any clinically important cardiovascular, pulmonary, hepatic, renal, dermal, central nervous system (CNS), or neuromuscular disease disorders or asthma (excluding non current, childhood asthma) or diabetes or any other clinically important disorder, as determined by the Investigator.
- Has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs or any condition that may confound the PK analyses, particularly hepatic or renal disease, as determined by the Investigator.
- Has a history of anaphylaxis, or other severe reaction, to a drug, food, toxin, or other exposure.
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 AcetateAlso: ZytigaATRS-2002 | Drug | Oral Abiraterone Acetate, SC ATRS-2002 |
Primary outcome
Pharmacokinetic assessment
Time frame: Pre-dose (within 30 minutes), Post dose - 4hours, 8hours, 12hours on day 1 and then 24hours, 36hours, 48hours, 60hours, 72hours, 84hours, 96hours, 168hours, 240hours, 336hours, 504hours, 672hours
Peak concentration (CMAX)
Pharmacodynamic assessment
Time frame: Pre-dose (within 30 minutes), Post dose - 4hours, 8hours, 12hours on day 1 and then 24hours, 36hours, 48hours, 60hours, 72hours, 84hours, 96hours, 168hours, 240hours, 336hours, 504hours, 672hours
To determine TT (total testosterone) and LH (luteinizing hormone) levels from whole blood
10 secondary outcomes
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1 and Days 1,3,5 and 15
Safety assessment
Time frame: Screening (Days -28 to -2), Predose - 4 hours, 8 hours, 12 hours, 24hours, 36hours, 48 hours, 72 hours and 96 hours. Vital signs will also be measured on Day 8, 11, 15, 22 and 29.
Safety assessment
Time frame: Screening (Days -28 to -2), Predose - 4 hours, 8 hours, 12 hours, 24hours, 36hours, 48 hours, 72 hours and 96 hours. Vital signs will also be measured on Day 8, 11, 15, 22 and 29.
Safety assessment
Time frame: Screening (Days -28 to -2), Predose - 4 hours, 8 hours, 12 hours, 24hours, 36hours, 48 hours, 72 hours and 96 hours. Vital signs will also be measured on Day 8, 11, 15, 22 and 29.
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1, Day 3, Day 8, Day15 and Day 29
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1 and Days 3, 5, 8, 11, 15, 22, and Day 29
Safety assessment
Time frame: Screening (Days -28 to -2) and Day 29
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1, Day 3, Day 5, Day 15, Day 29
Local tolerability
Time frame: Pre-dose, post dose-4 hours, 8hours, 12hours, 24hours, 36hours, 48hours, 72hours and 96 hours. Inspection will also be done at FU visits on Day 8, 11,15, 22 and 29
Local tolerability
Time frame: Immediately after SC dosing on day 1, 4, 8, 12, 24, 36, 48, 60, 72 and 96 hrs post dose. On day 8-to measure pain 11-point numeric pain rating scale will be used
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abiraterone Acetate in people with Metastatic Castration-resistant Prostate Cancer, run by Syneos Health.
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 14 inclusion and 21 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: withdrawn, as of the sponsor's last update on 28 Apr 2023. 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 withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic assessment (time frame: Pre-dose (within 30 minutes), Post dose - 4hours, 8hours, 12hours on day 1 and then 24hours, 36hours, 48hours, 60hours, 72hours, 84hours, 96hours, 168hours, 240hours, 336hours, 504hours, 672hours). 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 28 Apr 2023.