Detect GHB

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aarhus University

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

8 Nov 2022 → 29 Aug 2025

Decision date (initial)

2022-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Rådet for Offerfonden (Civilstyrelsen, Danish Ministry of Justice)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

The primary objective is to investigate whether one or more of the identified potential biomarkers can be detected longer than GHB itself in blood.

Secondary objectives 8

1. To investigate whether one or more of the identified potential biomarkers can be detected longer than GHB itself in urine, oral fluid, or hair
2. To investigate if we can identify the same potential biomarkers of GHB in a controlled, clinical trial, as was previously found using the DUID database
3. To investigate whether we find other metabolites or metabolite-protein conjugates associated to ingestion of GHB that appear up to 5 days after ingestion of GHB
4. To investigate whether GHB and the identified possible biomarkers of GHB can be detected in dental calculus using a new method, that has been developed at the Department of Forensic Chemistry, Aarhus University, and has been acknowledged internationally
5. To investigate whether intake of GHB can be detected in clothing worn during and until 1 day after administration
6. To investigate whether GHB affects the memory of the participant
7. To investigate whether the participants appear visibly affected by the drug
8. To validate which concentrations of GHB and possible biomarkers that can be detected by the routine screening method on the Department of Forensic Chemistry at Aarhus University.

Conditions and MedDRA coding

Intoxication

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Healthy volunteers aged 18-65 years
2. Informed, written consent
3. Able to understand Danish

Exclusion criteria 11

1. Current or previous substance abuse or alcohol abuse
2. Current or previous treatment with GHB
3. Treatment with valproate or topiramate
4. Treatment with benzodiazepines, opioids, or another CNS-depressant medicinal product
5. Hypersensitive to sodium oxybate or any of the excipients of Sodium Oxybate (i.e. malic acid and sodium hydroxide)
6. Succinic semialdehyde dehydrogenase deficiency
7. History of impaired hepatic or renal function
8. A diagnosis of epilepsy
9. A diagnosis of porphyria
10. A psychiatric disorder that requires medical treatment, incl. major depression
11. Pregnant and breastfeeding women (Fertile women (defined as amenorrhea for less than 12 months) must have a negative HCG pregnancy test prior to intake of the trial medication)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end point of the trial is the time until the longest detectable biomarker in blood is no longer up- or downregulated in the active treatment group compared to the placebo group.

Secondary endpoints 8

1. Time until the longest detectable biomarker in urine, oral fluid, or hair is no longer up- or downregulated in the active treatment group compared to the placebo group.
2. Fold change in biomarkers identified in a previous study as listed in table 1 in a previous study of Wang, T. et al. (Retrospective Metabolomics Analysis of Gamma-Hydroxybutyrate in Humans: New Potential Markers and Changes in Metabolism Related to GHB Consumption)
3. Fold change in metabolites in blood, urine, and oral fluid in all samples collected over time as analysed by metabolomics.
4. Concentration of GHB and identified biomarkers in dental calculus at one, two, and four weeks.
5. Concentration of GHB in absorbed sweat 1 day after intake of study medication.
6. Verbal Paired Associates (VPA) score 1.5 hours after intake for GHB.
7. Effect of drug on physical appearance 1.5 hours after intake (yes/no).
8. Concentration of GHB and possible biomarkers detected by routine screening.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus University

Sponsor organisation

Aarhus University

Address

Palle Juul-Jensens Boulevard 82

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Aarhus University

Contact name

Charlotte Uggerhøj Andersen

Public contact point

Organisation

Aarhus University

Contact name

Charlotte Uggerhøj Andersen

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Layperson summary Annex V

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications