Status:
COMPLETED
Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
Pharmacokinetic Interactions
HIV
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Gamma-hydroxybutyric acid (GHB) is a popular "party drug" because it is inexpensive and easy to ingest. The calming and euphoric effects of GHB in low doses have given the drug the nickname "liquid ec...
Detailed Description
Gamma-hydroxybutyric acid (GHB) is an endogenous compound present in most mammalian tissues at nanomolar concentrations and a minor metabolite or precursor of gammaaminobutyric acid (GABA). GHB was fi...
Eligibility Criteria
Inclusion
- Males and females\* aging 18-45 years.
- Body weight ranging between 50 and 100 Kg.
- Previous experience with the consumption of sedatives (alcohol, cannabis, benzodiazepines, GHB or other hypnotics).
- Absence of abnormalities in the screening ECG and blood/urine tests.
- Agree with the study procedures and signature of the informed consent.
- Women of childbearing potential must have a negative pregnancy test prior to randomization into the study and commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study. Condom use is considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.
- Based on ICH, M3 (R2) 2009 a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include tubal ligation, hysterectomy, bilateral oophorectomy.
Exclusion
- Prior history of medical or psychiatric adverse reaction following GHB consumption.
- Current substance use disorder (DSM-V, dependence, addiction) of any drug or substance of abuse.
- Prior history of substance use disorder (DSM-V, drug use disorder or addiction) of any drug or substance of abuse (except nicotine).
- Smokers\>10 cigarettes/day.
- History of any physical condition or major surgery within the previous three months.
- History of individual psychiatric conditions or schizophrenia in first-degree relatives.
- History of gastrointestinal, hepatic, renal diseases or other conditions which, in opinion of the investigator, may affect drug absorption, distribution, metabolism or elimination.
- Alcohol intake higher than 4 units/day (40 g) in men or 2 units/day (20 g) in women.
- Positive urine drug test (Amphetamines, Barbiturates, Benzodiazepines, Cocaine, MDMA, Methamphetamine, Morphine/Opioids, Methadone, tricyclic antidepressants, THC)
- HIV infection, chronic hepatitis C (IgG VHC) or B (HBsAg).
- Lactose intolerance
- Pregnancy, lactation, or planned pregnancy during the study period.
- Current or recent pharmacological treatment (≥3 doses per week) in the last 2 weeks
- Blood donation in the 3 previous months
- Participation in another clinical trial in the previous 3 months
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04322214
Start Date
January 30 2020
End Date
April 30 2020
Last Update
July 22 2020
Active Locations (1)
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1
José
Badalona, Barcelona, Spain, 08916