Interaction Between a Natural Aldehyde Dehydrogenase 2 (ALDH2) Inhibitor and Alcohol

NCT02309801 | Completed Phase 1 DMC

• 1 other identifier: PSMAR/IMIM/COCADEP/2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2 (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in humans.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-Time curve (AUC 2-10h)

  Calculation of AUC for blood alcohol concentrations

  From 2h to 10h after the first administration

Secondary Outcomes (8)

• Change in signs and symptoms of disulfiram-like reaction

  From baseline to 10h after the first administration

• Change in drunkenness and euphoria effects

  From baseline to 10h after the first administration

• Area Under the Concentration-Time curve (AUC 0-10h)

  From baseline to 24h after the first administration

• Number of participants with Serious and non-serious adverse events

  3 days after each condition

• Change in other subjective effects

  From baseline to 10h after the first administration

Study Arms (2)

Daidzin and alcohol

EXPERIMENTAL

Daidzin 80 mg, single dose, oral administration (4 capsules of Super-Absorbable Soy Isoflavones®). Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml.

Dietary Supplement: Daidzin; Dietary Supplement: Alcohol

Alcohol

ACTIVE COMPARATOR

Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml.

Dietary Supplement: Alcohol

Interventions

Daidzin DIETARY_SUPPLEMENT

Super-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein).

Daidzin and alcohol

Alcohol DIETARY_SUPPLEMENT

Alcohol single oral dose

Alcohol; Daidzin and alcohol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understanding and accepting the study procedures and signing the informed consent
• Clinical history and physical examination demonstrating no organic or psychiatric disorders
• The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically
• The body mass index (BMI=weigh/height2) will range from 19 to 27 kg/m2, and the weight from 50 to 100 kg
• Ethanol consumption of minimum 2 units per week and previous experience with ethanol intoxication
• Women with regular menstrual cycle (26-32 days)

You may not qualify if:

• History or clinical evidence of alcoholism, psychiatric disorders, drug abuse or dependence, or regular use of psychoactive drugs
• Having suffered any organic disease or major surgery in the three months prior to the study start
• Smokers
• Consumption of more than five coffees, teas, colas, other stimulant or xanthine beverages daily in the three months prior to the beginning of the study
• Taking more than 20 g of alcohol per day in women and 40 g of alcohol per day in men
• Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks
• Subjects with allergy, intolerance or adverse reactions to alcohol, soya and lactose.
• History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs
• Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed
• Subjects with positive serology to Hepatitis B, C or HIV
• Pregnant or breastfeeding women. Women not using effective contraceptive methods
• History or presence of breast cancer

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (1)

Parc de Salut Mar.

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Interventions

daidzin; Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Magí Farré, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: July 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

ES (1)