Overview

Phase 1 Study of ATRS-2002 in Healthy Male Adults

Status:
Not yet recruiting
Trial end date:
2021-12-28
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Syneos Health
Collaborator:
Antares Pharma Inc.
Treatments:
Abiraterone Acetate
Criteria
Inclusion Criteria:

1. Voluntarily provide written informed consent for participation in the study.

2. Be a male 18 to 55 years of age, inclusive at the time of consent.

3. Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening.

4. Have a normal electrocardiogram (ECG) at screening.

5. Have normal results for hematology, biochemistry, 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.

6. Have a potassium level greater than or equal to 3.8 mEq/L.

7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within the normal
range at screening.

8. Have a normal lipid profile at screening.

9. Have a testosterone value within the normal range at screening.

10. 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.

11. 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 90 days post-dose:

1. Simultaneous use of a condom and, for the female partner, hormonal contraceptives
(used since at least 4 weeks);

2. Simultaneous use of a male condom and, for the female partner, intra-uterine
contraceptive device (placed since at least 4 weeks).

12. 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.

13. Must be willing not to donate sperm until at least 120 days post-dose

14. Be able and willing to comply with all study procedures and agree to participate in
the study program as outlined in the protocol.

Exclusion Criteria:

1. Has a known allergy to study drug or any excipients contained within the study drug.

2. 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).

3. 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.

4. 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.

5. Has a history of anaphylaxis, or other severe reaction, to a drug, food, toxin, or
other exposure.

6. Has an elevated PSA level at screening.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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]).

12. Has a positive breathalyzer test at screening or at check-in (Day -1).

13. 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).

14. 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.

15. Has a positive urine cotinine test at screening or at check-in (Day -1).

16. Has donated blood or plasma within 90 days prior to the screening visit.

17. 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.

18. Has a history of suicidal ideation, suicide attempts, or psychiatric hospitalizations.

19. Has a positive result for Human Immunodeficiency Virus (HIV) 1/2 antibody, hepatitis C
antibody, or hepatitis B surface antigen.

20. 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.

21. Has adrenal insufficiency or has used oral or inhaled corticosteroids within the past
12 months before the screening visit.