Phase 1 Study of ATRS-2002 in Healthy Male Adults

NCT04879589 | Withdrawn Phase 1 DMC

• 1 other identifier: ATRS-2002-20-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic assessment

  Peak concentration (CMAX)

  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

  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

  Screening (Days -28 to -2), Day -1 and Days 1,3,5 and 15

• Safety assessment

  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

  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

  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

  Screening (Days -28 to -2), Day -1, Day 3, Day 8, Day15 and Day 29

Study Arms (2)

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.

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

Drug: Abiraterone Acetate

Interventions

Abiraterone Acetate DRUG

ATRS-2002

Also known as: Zytiga

Oral Abiraterone Acetate; SC ATRS-2002

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Syneos Health: lead
• Antares Pharma Inc.: collaborator

MeSH Terms

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 10, 2021
• Study Start: September 1, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: April 28, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share