A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects

What this trial studies

The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.

Conditions in scope

• Healthy Subjects

Interventions

• ESN364 (Drug) — ESN364 will be administered orally.
• Placebo (Drug) — Placebo will be administered orally.

Who can join

All sexes · Ages 20 Years to 64 Years · Accepts healthy volunteers.

Inclusion criteria

• Male subject between 20 to \< 45 years of age, or female subject between 20 to \< 65 years of age.
• Body weight at screening: ≥ 50.0 kg and \< 80.0 kg for male, ≥ 40.0 kg and \< 70.0 kg for female.
• Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and \< 26.4 kg/m2 \[BMI = Body weight (kg) ÷ {Body height (m)2}\].

Exclusion criteria

• Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
• Subject has had previous exposure with ESN364.
• Subject has any clinically significant history of allergic conditions prior to study drug administration.
• Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
• Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
• Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission.
• Subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission.
• Subjects who are positive for any of urinary drug abuse test or serology test at screening.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2018-02-22
• Primary completion: 2018-05-23
• Last update posted: 2024-10-16
• First posted: 2018-02-19

Sponsor & contact

Lead sponsor: Astellas Pharma Inc (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Safety assessed by incidence of adverse events (AEs) in Part 1 (Up to Day 12 in Part 1)
  AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
• Safety assessed by incidence of AEs in Part 2 (Up to Day 24 in Part 2)
  AEs will be coded using MedDRA.
• Safety assessed by vital signs: Body temperature in Part 1 (Up to day 12 in Part 1)
  To assess vital signs as a criterion of safety variables.
• Safety assessed by vital signs: Body temperature in Part 2 (Up to Day 24 in Part 2)
  To assess vital signs as a criterion of safety variables.
• Safety assessed by vital signs: Blood pressure in Part 1 (Up to Day 12 in Part 1)
  To assess vital signs as a criterion of safety variables.

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