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Drug Res (Stuttg) 2017; 67(04): 204-210
DOI: 10.1055/s-0042-123826
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Influence of Tiopronin on the Metabolism of Alcohol in Healthy Subjects

Friederike Nass
1   Institute of General Practice, Gemeinschaftspraxis Dr. Pelzer, Dr. Dr. Kroll, University Hospital Düsseldorf, Kleve, Germany
,
Berthold Schneider
2   Institute of Biometry, Hannover Medical School, Hannover, Germany
,
Stefan Wilm
3   Institute of General Practice, University Hospital Düsseldorf, Düsseldorf, Germany
,
Bernd Kardel
4   Institute of Forensic Medicine, University Hospital Düsseldorf, Düsseldorf, Germany
,
Elisabeth Gabor
5   Pharmakovigilanz, MIT Gesundheit GmbH, Kleve, Germany
,
Fabian Merges
5   Pharmakovigilanz, MIT Gesundheit GmbH, Kleve, Germany
,
Michael Kroll
6   Institute of General Practice, Gemeinschaftspraxis Dr. Pelzer, Dr. Dr. Kroll, Kleve, Germany
› Author Affiliations
Further Information

Publication History

received 20 September 2016

accepted 07 December 2016

Publication Date:
31 January 2017 (online)

Also available at
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Abstract

Background

Drug safety- and drug-alcohol interaction studies have mainly been conducted for frequently prescribed drugs with high financial interests. Orphan drugs such as tiopronin (ORPHA25073) are often neglected in terms of clinical research. Tiopronin is a drug that is mainly used for the treatment of cystinuria. In this study, the interaction of tiopronin regarding the metabolism of alcohol (primary objective), and the safety of tiopronin in combination with alcohol was tested in healthy volunteers.

Methods

In this randomised, double-blind, cross-over study, 13 healthy subjects received 500 mg tiopronin or an identical looking placebo 1 h before the intake of 0.8 g of alcohol per kg of bodyweight. Blood alcohol concentrations were measured over the course of 12 h after consumption. The experiment was repeated 7 days later with the previous placebo group receiving the active drug and vice-versa. Changes in blood alcohol AUC and elimination rate k were analysed using a 2-tailed t-test. Further acetaldehyde concentrations were measured. Additionally, the concentration ability of the subjects was tested and any adverse effects were recorded.

Results

There was no significant change in blood alcohol or acetaldehyde concentration. Significant differences in concentration tests refer presumably to learning effects. No serious adverse event occurred. All adverse events were reversible and there was no significant difference in occurrence between drug and placebo group.

Conclusion

It was demonstrated that tiopronin does not affect the metabolism of alcohol. Intake of tiopronin in combination with alcohol has no safety implications on healthy subjects.

Key words

cystinuria - orphan drug - ethanol
 

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