MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function

Launched by LYKOS THERAPEUTICS · Jul 20, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at how the drug MDMA is processed in people with moderate liver problems compared to those with normal liver function. The main goal is to see if individuals with liver issues absorb MDMA differently and whether their dosage needs to be adjusted.

To participate, you need to be between 18 and 65 years old and weigh more than 45 kg. You should either have moderate liver impairment or normal liver function, as determined by certain medical tests. Participants will take a single dose of MDMA and then stay at the study site for two days for monitoring. During this time, researchers will check vital signs and ask about any side effects or feelings experienced after taking the drug. It’s important to know that this trial is not yet recruiting participants, and there are specific health criteria that must be met to qualify. If you have any questions or concerns about your eligibility, it’s best to discuss them with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria).
• • Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters.
• • Age 18 to 65 years.
• • Weight \> 45 kg
• • Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration.
• • Negative urine test for drugs of abuse at Screening and prior to trial drug administration.
• • Able to comprehend and willing to sign an informed consent form.
• Exclusion Criteria:
• • Have a current psychiatric diagnosis.
• • Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control.
• • Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 2 weeks.
• • Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices.
• • Have spontaneous bacterial peritonitis within 3 months prior to screening.
• • Have a portosystemic shunt, organ transplant, Wilson's disease, cholestatic liver disease (e g, primary biliary cirrhosis or primary sclerosing cholangitis)
• • Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular (including controlled hyper-tension), coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration.
• • For moderate hepatic impairment participants: have clinically significant laboratory findings except as related to hepatic impairment.
• • For control participants only: have clinically significant laboratory results outside the normal limits, including AST \>48 U/L, ALT \> 55 U/L, GGT \> 48 U/L, bilirubin \> 1.2 mg/dL or hemoglobin \< 12 g/dL.
• • Have a history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject.
• • Have any positive test for drugs of abuse and /or alcohol at screening.
• • Have a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \> 450 ms in men, \> 470 ms in women on the screening ECG.
• • Have a PR interval \> 240 ms, QRS \> 110 ms or a history of prolongation of QT interval.
• • Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation.
• • Are unwilling to stay in the clinical unit for the required duration as per the protocol.
• • Have a known or suspected allergy to trial product or related products.