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

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ClinicalTrials.gov Identifier: NCT02134834
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Meiji Seika Pharma Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Bacterial Infections Drug: OP0595 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Ascending single dose of OP0595 Drug: OP0595
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Placebo Comparator: Normal Saline Drug: Placebo
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation




Primary Outcome Measures :
  1. Safety from baseline through the end of the study [ Time Frame: Day 1 to Day 7 ]
    Number of patients with adverse events


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134834


Locations
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Australia, Western Australia
Perth,, Western Australia, Australia
Sponsors and Collaborators
Meiji Seika Pharma Co., Ltd.
Investigators
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Study Chair: Mitsuharu Egawa Meiji Seika Pharma Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meiji Seika Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02134834    
Other Study ID Numbers: OP0595-1
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Bacterial Infections