How liver impairment changes MDMA blood levels in people with and without normal liver function

You may qualify if

• 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.

You can't join if

• 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.