Recruiting

Toxicokinetics

Sponsor:

Université de Montréal

Code:

NCT02659410

Conditions

Heat

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Heat stress (21)

Heat stress (25)

Heat stress (30)

Heat Stress (21) +TOL

Heat stress (25) + TOL

Study Details

Brief 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.

Conditions

Heat

Study ID

NCT02659410

Start date

Nov, 2015

Status verified date

Jan, 2016

Completion date

Jun, 2018

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Accepted

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

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Heat stress

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

Interventions

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.

Primary outcome measure

  • Respiratory rate [ Time Frame: 4hour ]
  • Cardiac frequency [ Time Frame: 4hour ]
  • Minute ventilation [ Time Frame: 4hour ]
  • Tidal volume [ Time Frame: 4hour ]
  • Solvent in blood [ Time Frame: 4,5hour ]
  • Solvent or metabolite in urine [ Time Frame: 18hour ]
  • Solvent in exhaled air [ Time Frame: 6hour ]

Central Contacts and Locations

Central contacts

Sami Haddad, Ph.D

514-343-6111sami.haddad@umontreal.ca

Locations

Université de Montréal

Recruiting

Montreal, Quebec, Canada, H3T 1J4

Contacts

Sami Haddad, Ph.D

514-343-6111sami.haddad@umontreal.ca

Principal Investigator:

Sami Haddad, PhD

More Information

Sponsor

Université de Montréal

Last update posted

Jan 20, 2016

Last verified

Jan, 2016

Keywords

  • Physiologically based pharmacokinetic modeling
  • Organic solvents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2016-01-20.