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This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Lu AF88434 or Placebo | Experimental | 6 cohorts (cohort A1 to A6) with 9 subjects in each cohort. In each cohort 6 subjects will receive single doses of Lu AF88434 and 3 subjects will receive placebo |
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| Part B1 Lu AF88434 Fed-Fasting-Fasting | Experimental | 4 subjects will receive an identical oral dose of Lu AF88434 in Group B1. The treatment sequence for Group B1 is: Fed-Fasting-Fasting. 14C-spiked dose (Lu AF99723) will be given in the last treatment sequence. |
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| Part B2 Lu AF88434 Fasting-Fed-Fasting | Experimental | 4 subjects will receive an identical oral dose of Lu AF88434 in Group B2. The treatment sequence for Group B2 is: Fasting-Fed-Fasting. 14C-spiked dose (Lu AF99722) will be given in the last treatment sequence. |
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| Part B3 Lu AF88434 Fasting-Fasting-Fed | Experimental | 4 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF88434 | Drug | Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters) | From screening to Day 11 |
| Cmax Lu AF88434 | Maximum observed plasma concentration | From 0 to 96 hours |
| AUC(0-inf) Lu AF88434 | Area under the plasma concentration time curve from zero to infinity | From 0 to 96 hours |
| CL/F Lu AF88434 | Oral clearance for Lu AF88434 in plasma | From day 1 to day 5 |
| Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) | From 0 to Day 14 | |
| Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) | From 0 to Day 14 |
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Inclusion Criteria:
-Healthy young non-smoking men with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.
Exclusion Criteria:
Other inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS | Groningen | Netherlands |
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| Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) | Drug | Oral solution |
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| Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) | Drug | Oral solution |
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| Placebo | Drug | Placebo to Lu AF88434 oral solution, single dose |
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