NCT01751269

Brief Summary

RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2012

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

December 13, 2012

Last Update Submit

July 22, 2013

Conditions

Healthy VolunteersBacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Safety from baseline through the end of the study.

    Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

    Study Day 1 to Day 13.

Secondary Outcomes (1)

  • Composite of PK parameters RPX7009 & placebo following single dose administration.

    Study Day 1 to Day 12

Study Arms (2)

Ascending Single and Multiple dose of RPX7009

EXPERIMENTAL

Ascending Single and Multiple dose of RPX7009

Drug: RPX7009

Normal Saline

PLACEBO COMPARATOR

Ascending Single and multiple dose of normal saline.

Drug: Placebo

Interventions

RPX7009DRUG

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Also known as: (beta-lactamase inhibitor)
Ascending Single and Multiple dose of RPX7009
PlaceboDRUG

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Also known as: Normal saline
Normal Saline

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age
  • Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
  • Medically healthy with clinically insignificant screening results
  • Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
  • Sexually abstinent or use acceptable methods of birth control

You may not qualify if:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
  • Documented hypersensitivity reaction or anaphylaxis to any medication.
  • Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
  • Plasma donation within 7 days prior to Day 1.
  • Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • Griffith DC, Loutit JS, Morgan EE, Durso S, Dudley MN. Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the beta-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6326-32. doi: 10.1128/AAC.00568-16. Print 2016 Oct.

    PMID: 27527080DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

RPX7009beta-Lactamase InhibitorsSaline Solution

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnti-Bacterial AgentsAnti-Infective AgentsTherapeutic UsesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jefferey Loutit, MBChB

    Sponsor GmbH

    STUDY DIRECTOR

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

December 13, 2012

First Posted

December 17, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

AU(1)