Pentriox - Induction of Oxidative Stress

NCT02188472 | Completed Phase 1 DMC

• 1 other identifier: PEN1011
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and trimethoprim's possible induction of oxidative stress in human cells. The induction is examined by comparing changes in oxidative stress in the treatment group with the change in a placebo group. The study is a randomized-based placebo-controlled study. Each treatment group consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.

Conditions

Oxidative Stress

Keywords

Oxidative Stress; antibiotics

Outcome Measures

Primary Outcomes (2)

• Urinary excretion of 8-oxoguanosine (nmol/24h)

  Change from Baseline after seven days of treatment

• Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)

  Change from Baseline after seven days of treatment

Secondary Outcomes (1)

• Malondialdehyde

  At the screening visit and at the final visit

Study Arms (3)

Penicillin V

ACTIVE COMPARATOR

Penicillin V 2 tablets of 330 mg twice dayly for 7 days

Drug: Penicillin V

Trimethoprim

ACTIVE COMPARATOR

2 Tablet Trimethoprim of 100 mg twice daily for 7 days

Drug: Trimethoprim

Placebo

PLACEBO COMPARATOR

2 Placebo Tablets twice daily for 7 days

Drug: Placebo

Interventions

Penicillin V DRUG

Penicillin V: 2 x 330mg tablets should be taken twice daily

Also known as: Penicillin V, Pancillin

Penicillin V

Trimethoprim DRUG

Trimopan: 2 x 100mg tablets should be taken twice daily

Also known as: Trimethoprim, Trimopan

Trimethoprim

Placebo DRUG

Placebo: 2 tablets should be taken twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian
• healthy men
• non-smoker
• years
• BMI: 18-30

You may not qualify if:

• Smoker
• high blood pressure
• allergies towards any of the tested medicine
• galactose-intolerance
• abnormal lipid profile
• CRP \> 10
• Glucose/galactose-malabsorption
• Use of medications and herbal remedies that affect/are affected by v-penicillin and trimethoprim
• intake of narcotics 2 months prior to trial
• intake of supplements 1 month prior to trial
• bronchial asthma
• allergies
• heart deficiencies
• brady cardia
• kidney disease

Sponsors & Collaborators

• Henrik Enghusen Poulsen: lead
• Klinisk Biokemisk Afdeling: collaborator
• Klinisk farmakologisk Afdeling: collaborator
• Sektion for Biomedicin Institut for Veterinær Patobiologi: collaborator

Study Sites (1)

Department of Clinical Pharmacology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Penicillin V; Trimethoprim

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Henrik E Poulsen, MD

  Department head

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: July 11, 2014
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

DK (1)