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Completed

NCT Number: NCT02134834

A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595

The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.

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Key information

Conditions

Healthy Volunteers Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Perth, Western Australia, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian males aged between 18 and 45 years (inclusive) at Screening
  • A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
  • Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
  • Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1

Exclusion criteria

  • Receipt of any investigational agent or drug within four months before Screening
  • A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
  • Hypersensitivity and/or allergy to drugs
  • Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
  • A history of chronic or recurrent infections or current active infection
  • A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
  • A history or presence of malignancy
  • Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
  • A history of smoking at any time within one year before Screening

Treatment and study plan

OP0595

Drug

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Placebo

Drug

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Primary outcomes

  1. Safety from baseline through the end of the study

    Time frame: Day 1 to Day 7

    Number of patients with adverse events

Secondary outcomes

  1. Plasma PK parameters of OP0595 and its metabolites

    Time frame: Day 1 to Day 2

    Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss

  2. Urine PK parameters of OP0595 and its metabolites

    Time frame: Day 1 to Day 2

    Ae, Ae0-t, Ae0-t/Dose, CLr

Sponsors and collaborators

Lead sponsor

Meiji Seika Pharma Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 9, 2014
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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