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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Safety from baseline through the end of the study [ Time Frame: Day 1 to Day 7 ]
Number of patients with adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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
  • Urine PK parameters of OP0595 and its metabolites [ Time Frame: Day 1 to Day 2 ]
    Ae, Ae0-t, Ae0-t/Dose, CLr
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy Volunteers
  • Bacterial Infections
Intervention  ICMJE
  • Drug: OP0595
    Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
  • Drug: Placebo
    Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
Study Arms  ICMJE
  • Experimental: Ascending single dose of OP0595
    Intervention: Drug: OP0595
  • Placebo Comparator: Normal Saline
    Intervention: Drug: Placebo
Publications * Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel β-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5). pii: e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134834
Other Study ID Numbers  ICMJE OP0595-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meiji Seika Pharma Co., Ltd.
Study Sponsor  ICMJE Meiji Seika Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mitsuharu Egawa Meiji Seika Pharma Co., Ltd.
PRS Account Meiji Seika Pharma Co., Ltd.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP