A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Ascending Doses of ASP7962 in Healthy Subjects (MAD)

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Pharmacokinetics of ASP7962

Treatments: Drug: ASP7962; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02136316

7962-CL-0002

2014-000159-95 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability as well as the pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and female subjects.

Full description

Subjects will be admitted to the clinical unit and will stay residential for a total of 20 days/19 nights, to be discharged from the clinical unit on day 19.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject has a body mass index of 18.5 - 30.0 kg/m2, inclusive. Subject weighs at least 50 kg.

• Female subject must be of non-childbearing potential:

  • Postmenopausal (defined as at least 1 year without any menses and confirmation of FSH levels) prior to screening, or
  • Documented surgically sterile or status post-hysterectomy (at least 1 month prior to screening).

• Male subject and their female spouse/partner who are of childbearing potential must be using 2 highly effective forms of birth control (1 of which must be a barrier method) starting at screening and continued throughout the clinical study period, and for 90 days after the final study drug administration.

• Male subject must not donate sperm starting at screening, throughout the clinical study period, and for 90 days after the final study drug administration.

• Subject agrees not to participate in another interventional study while participating in the present clinical study, defined as signing the informed consent form until completion of the last study visit.

Exclusion criteria

• Subject has a known or suspected hypersensitivity to ASP7962 or any components of the formulation used.
• Subject has a history of suicide attempt or suicidal behavior. Any suicidal ideation within the last 3 months.
• Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal [ULN]. In such a case the assessment may be repeated once [day -1].
• Subject has any clinically significant history of allergic conditions.
• Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit on day -1.
• Subject has a mean pulse rate < 40 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DPB) > 90 mmHg (vital sign measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse rate will be measured automatically) [day -1]. If the mean pulse rate, mean SBP or mean DBP is out of the range as specified above, 1 additional triplicate measurement may be taken on day -1.
• Subject has a mean corrected QT interval using Fridericia's formula (QTcF) interval > 430 ms (for male subjects) and > 450 ms (for female subjects) on admission to the clinical unit on day 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken [day -1].
• Subject uses any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day).
• Subject has used nicotine-containing products within 6 months prior to admission to the clinical unit.
• Subject has a history of drinking more than 21 units of alcohol per week for male subjects or 14 units of alcohol per week for female subjects (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit.
• Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
• Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit.
• Subject has had a significant blood loss, donated 1 unit (500 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit.
• Subject has a positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at screening.
• Subject has participated in any clinical study or has been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Subject is an employee of the Astellas Group or Contract Research Organization involved in the clinical study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

ASP7962 low dose

Experimental group

Treatment:

Drug: ASP7962

ASP7962 medium dose

Experimental group

Treatment:

Drug: ASP7962

ASP7962 high dose

Experimental group

Treatment:

Drug: ASP7962

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo