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

NCT02134834 | Completed Phase 1

• 1 other identifier: OP0595-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Safety from baseline through the end of the study

  Number of patients with adverse events

  Day 1 to Day 7

Secondary Outcomes (2)

• Plasma PK parameters of OP0595 and its metabolites

  Day 1 to Day 2

• Urine PK parameters of OP0595 and its metabolites

  Day 1 to Day 2

Study Arms (2)

Ascending single dose of OP0595

EXPERIMENTAL

Drug: OP0595

Normal Saline

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OP0595 DRUG

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

Ascending single dose of OP0595

Placebo DRUG

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

Normal Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meiji Seika Pharma Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Perth, Western Australia, Australia

Location

Related Publications (1)

• 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 beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.

  PMID: 32041717 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

nacubactam

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Mitsuharu Egawa

  Meiji Seika Pharma Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

AU (1)