Major Depressive Disorder
Conditions
Interventions
The IMPs in this study are:
Lu AF90103 - 50 mg, powder for solution for infusion, intravenous
Placebo * powder for solution for infusion, intravenous
Sponsors
Lundbeck
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The subject is able to read and understand the Informed Consent Form. 2. The subject has signed the study-specific Informed Consent Form. 3. The subject is a man 4. The subject is *18 and *45 years of age at the Screening Visit for Cohorts A1 to A6 (excluding cohort A2b) or *55 to *65 for subjects in the CSF sampling Cohorts A2b and A7. 5. The subject has a BMI *18.5 and *30 kg/m2, body weight *60kg, at the Screening Visit and at the Baseline Visit.
Exclusion criteria
Exclusion criteria: 1. The subject has taken disallowed medication 430 ms (Fridericia*s correction) at the Screening Visit, as calculated by the ECG equipment and evaluated by the investigator. The ECG may be repeated if any of the values are out of range or abnormal. 4. The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. 5. The subject has a family history of psychosis in a first degree relative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Endpoints Safety * adverse events * absolute values and changes from baseline in clinical safety laboratory test values (incl. urine kidney biomarkers), vital signs, weight, and ECG parameter values * potentially clinically significant clinical safety laboratory test values (incl. urine kidney biomarkers), vital signs, weight changes, and ECG parameter values * changes from baseline in the Psychotomimetic States Inventory (PSI) and the Clinically Administered Dissociative States Scale (CADSS), used to assess psychotomimetic side effects. Pharmacokinetics * area under the concentration-time curve from zero to infinity in plasma and CSF (AUC0-inf) for Lu AF90103 and Lu AF88361, defined as AUC0-t + Clast × t* / ln2 (where Clast is the last quantifiable concentration and t* is the apparent elimination half-life) * Concentration at time zero (C0) following infusion of Lu AF90103 in plasma, * maximum observed concentration (Cmax) in plasma and CSF for Lu AF88361 and in CSF for Lu AF90103 * total clearance, defined as dose / AUC0-inf (plasma) (CL) * apparent elimination half-life in plasma and CSF for Lu AF90103 and Lu AF88361 (t*) * nominal time corresponding to the occurrence of Cmax for Lu AF90103 in CSF and Lu AF88361 in plasma and CSF (tmax) * apparent volume of distribution, defined as CL × t* / ln2 (Vz) * Plot of a cumulative excretion and amount remaining to be excreted for Lu AF90103 and Lu AF88361 will made based on urine data. * Metabolic ratio (MR), defined as AUCmetabolite/AUC parent Pharmacodynamics -EEG * Changes to time matched baseline in AUC of medial prefrontal (FZ and CZ electrodes) high gamma (100-170 HZ) in the resting state | — |
Countries
Netherlands
Outcome results
None listed