Non-oxidative Metabolite Profiles After Increasing Doses of Ethanol

NCT02311686 | Completed Phase 1 DMC

• 1 other identifier: Biomarcadores/PNSD/1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of increasing doses of alcohol in adult subjects.

Conditions

Alcohol Consumption; Healthy

Keywords

Ethanol; Fatty acid ethyl esters; Ethyl glucoronide; Ethyl sulphate; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-Time Curve (AUC 0-24h)

  Calculation of the AUC for plasma fatty acid ethyl esters (palmitic, stearic, linoleic and oleic acid ethyl esters) concentrations. Blood samples will be obtained baseline and at 0,25, 0,50, 0,75,1, 1,25, 1,50, 1,75, 2, 2,5, 3, 3,5, 4, 5, 6, 8, 10, 24h. Additional samples will be collect at 72 h and 1 week, 1 and 2 months after administration. At 3 months a sample will be obtained in selected participants.

  From baseline to 24 hours after administration

Secondary Outcomes (10)

• Area Under the Concentration-Time Curve (AUC 0-24h)

  From baseline to 24 hours after administration

• Cumulative amount of drug excreted into urine up to collection time of last measurable concentration

  From baseline to 72 hours after administration

• Elimination half-life

  From baseline to 24 hours after administration

• Fatty acid ethyl esters and ethyl glucoronide hair concentrations

  Baseline, 1 and 2 months after administration

• Change in subjective effects of ethanol

  From baseline to 10 hours after administration

Study Arms (5)

10 g ethanol

EXPERIMENTAL

Subjects will be required to drink a dilution of 31 mL of vodka in 369 mL of lemon-flavored water in 15 minutes.

Dietary Supplement: 10 g ethanol

20 g ethanol

EXPERIMENTAL

Subjects will be required to drink a dilution of 63 mL of vodka in 337 mL of lemon-flavored water in 15 minutes.

Dietary Supplement: 20 g ethanol

40 g ethanol

EXPERIMENTAL

Subjects will be required to drink a dilution of 125 mL of vodka in 275 mL of lemon-flavored water in 15 minutes.

Dietary Supplement: 40 g ethanol

60 g ethanol

EXPERIMENTAL

Subjects will be required to drink a dilution of 188 mL of vodka in 212 mL of lemon-flavored water in 15 minutes.

Dietary Supplement: 60 g ethanol

80 g ethanol

EXPERIMENTAL

Subjects will be required to drink a dilution of 250 mL of vodka in 150 mL of lemon-flavored water in 15 minutes.

Dietary Supplement: 80 g ethanol

Interventions

10 g ethanol DIETARY_SUPPLEMENT

Alcohol single oral dose

Also known as: Vodka Absolut®

10 g ethanol

20 g ethanol DIETARY_SUPPLEMENT

Alcohol single oral dose

Also known as: Vodka Absolut®

20 g ethanol

40 g ethanol DIETARY_SUPPLEMENT

Alcohol single oral dose

Also known as: Vodka Absolut®

40 g ethanol

60 g ethanol DIETARY_SUPPLEMENT

Alcohol single oral dose

Also known as: Vodka Absolut®

60 g ethanol

80 g ethanol DIETARY_SUPPLEMENT

Alcohol single oral dose

Also known as: Vodka Absolut®

80 g ethanol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understand and accept the study's procedures and sign an informed consent form
• No evidence of somatic or psychiatric disorders as per past medical history and physical examination
• EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)
• Body mass index (BMI=weight/heigth2) between 19 and 29 kg/m2, weight between 50 and 100 kg (for the 60 and 80 g doses, subjects will be required to weigh a minimum of 67 kg)
• For premenopausal females, a regular menstrual cycle of 26-32 days duration.
• Social or recreational alcohol consumption of at least 1 unit per day (or its equivalent \[7 units\] over the whole week) and having experienced drunkenness several times

You may not qualify if:

• Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
• Previous psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs
• Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
• Individuals intolerant or having experienced a severe adverse reaction to alcohol
• Smokers of \>10 cigarettes/day
• Consumption of \>20 g/day of alcohol (females) or of \>40 g/day (males)
• Hepatitis B, hepatitis C or human immunodeficiency virus-positive individuals
• Pregnant or lactating women, or those using hormonal or unreliable contraceptive methods during the study period. Complete abstinence, intrauterine devices, double barrier methods or a vasectomized sexual partner will be considered acceptable
• Women with amenorrhea or suffering severe premenstrual syndrome
• Individuals of Asian ascent

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc de Salut Mar (IMIM)

Barcelona, Barcelona, 08003, Spain

Location

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MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Francina Fonseca, MD, PhD

  Parc de Salut Mar

  STUDY DIRECTOR

• Clara Pérez, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

ES (1)