NCT01772836

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
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2013

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

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

Same day

First QC Date

January 16, 2013

Last Update Submit

July 9, 2013

Conditions

Healthy VolunteersBacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Safety from baseline to 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.

    Day 1 - Day 17

Secondary Outcomes (2)

  • Composite of Pharmacokinetic (PK) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.

    Day 1 - Day 14

  • Composite of Pharmacodynamic (PD) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.

    Days 1-14

Study Arms (4)

Normal saline

PLACEBO COMPARATOR

Single and multiple dose of normal saline

Drug: Normal saline

Single dose IV of biapenem or RPX7009

EXPERIMENTAL

Single dose IV infusion of biapenem or RPX7009

Drug: RPX7009Drug: Biapenem

Single dose of biapenem or RPX7009

EXPERIMENTAL

Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment)

Drug: RPX7009Drug: Biapenem

Biapenem and RPX7009 in combination

EXPERIMENTAL

Single dose followed by a multiple dose of biapenem and RPX7009 in combination

Drug: RPX7009Drug: Biapenem

Interventions

RPX7009DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Also known as: (beta-lactamase inhibitor)
Biapenem and RPX7009 in combinationSingle dose IV of biapenem or RPX7009Single dose of biapenem or RPX7009
BiapenemDRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Also known as: RPX2003
Biapenem and RPX7009 in combinationSingle dose IV of biapenem or RPX7009Single dose of biapenem or RPX7009
Normal salineDRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Also known as: Placebo
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, 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.
  • Hypersensitivity or idiosyncratic reaction to beta-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, etc.).
  • 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

MeSH Terms

Conditions

Bacterial Infections

Interventions

RPX7009beta-Lactamase InhibitorsbiapenemSaline 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

January 16, 2013

First Posted

January 21, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

AU(1)