Impact of Thermal Stress on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

Heat Clinical Trial

Official title:

Studying the Impact of Thermal Stress (Heat) Representative of Occupational Settings on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659410
• Other study ID #: 14-140-CERES-P
• Secondary ID: 2013-0012
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2016
• Last updated: January 19, 2016
• Start date: November 2015
• Est. completion date: June 2018

Study information

• Verified date: January 2016
• Source: Université de Montréal
• Contact: Sami Haddad, Ph.D
• Phone: 514-343-6111
• Email: sami.haddad[@]umontreal.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds. Exposure to heat induces physiological responses that help maintaining a stable body temperature. Those changes can affect organ functions implicated in absorption and metabolism. According to literature, those changes could lead to increased concentrations of chemical compounds in the body and their toxicity. Therefore, the aim of this study is to evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress conditions in volunteers exposed in a inhalation chamber. Results will then be used to develop PBPK models that will allow to predict organic solvent kinetics when coexposed with heat.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body mass index between 18,5 et 25 kg/m3

Exclusion Criteria:

• Smoking

• Respiratory, cardiovascular and neurological problems

• History of exposure to solvents

• Chronic medication

• Abusive and/or chronic alcohol consumption

• Alcohol consumption 24h before or 18h following exposure

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heat

Intervention

Other:
• Heat stress (21)
4h exposure to heat (WBGT of 21°C), no solvent
• Heat stress (25)
4h exposure to heat (WBGT of 25°C), no solvent
• Heat stress (30)
4h exposure to heat (WBGT of 30°C), no solvent
• Heat Stress (21) +TOL
4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV)
• Heat stress (25) + TOL
4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV)
• Heat stress (21) + TOL
4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV)
• Heat stress (21) + ACE
4h exposure to heat (WBGT of 21°C) + Acetone (concentration = TLV)
• Heat stress (25) + ACE
4h exposure to heat (WBGT of 25°C) + Acetone (concentration = TLV)
• Heat stress (30) + ACE
4h exposure to heat (WBGT of 30°C) + Acetone (concentration = TLV)
• Heat stress (21) + DCM
4h exposure to heat (WBGT of 21°C) + Dichloromethane (concentration = TLV)
• Heat stress (25) + DCM
4h exposure to heat (WBGT of 25°C) + Dichloromethane (concentration = TLV)
• Heat stress (30) + DCM
4h exposure to heat (WBGT of 30°C) + Dichloromethane (concentration = TLV)
• Heat stress (21) + TOL (dermal)
4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.
• Heat stress (25) + TOL (dermal)
4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.
• Heat stress (30) + TOL (dermal)
4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.

Locations

Country	Name	City	State
Canada	Université de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate	Respiratory rate will be monitored continuously for 4hour with a respirometer	4hour	No
Primary	Cardiac frequency	Cardiac frequency will be monitored continuously for 4hour with a respirometer	4hour	No
Primary	Minute ventilation	Minute ventilation will be monitored continuously for 4hour with a respirometer	4hour	No
Primary	Tidal volume	Tidal volume will be monitored continuously for 4hour with a respirometer	4hour	No
Primary	Solvent in blood	Solvents concentrations will be measured in blood samples collected at different times (t=0, 2, 4 and 4.5hour).	4,5hour	No
Primary	Solvent or metabolite in urine	Solvent or metabolite concentrations (o-cresol for toluene exposures) will be measured for urine samples collected at different times (t=0, 4, 10 and 18hour).	18hour	No
Primary	Solvent in exhaled air	Solvents concentrations will be measured in exhaled air samples collected at different times (t=0, 1.5, 3, 4.5 and 6hour).	6hour	No
Secondary	Oxygen consumption	oxygen consumption will be monitored continuously for 4hour with a respirometer	4hour	No
Secondary	Carbonic dioxide production	carbonic dioxide production will be monitored continuously for 4hour with a respirometer	4hour	No
Secondary	Body temperature	Body temperature is monitored continuously by telemetry	4hour	No