A Phase 1 interventional study of Lu AF88434 and Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) in Healthy, sponsored by H. Lundbeck A/S. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
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
H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
-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
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
Drug: Lu AF88434 · Drug: Placebo
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.
Drug: Lu AF88434 · Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
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.
Drug: Lu AF88434 · Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
4 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed.
Drug: Lu AF88434
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).
Oral solution
Oral solution
Placebo to Lu AF88434 oral solution, single dose
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)
Time frame: From screening to Day 11
Cmax Lu AF88434
Maximum observed plasma concentration
Time frame: From 0 to 96 hours
AUC(0-inf) Lu AF88434
Area under the plasma concentration time curve from zero to infinity
Time frame: From 0 to 96 hours
CL/F Lu AF88434
Oral clearance for Lu AF88434 in plasma
Time frame: From day 1 to day 5
Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Time frame: From 0 to Day 14
Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Time frame: From 0 to Day 14
Plan to share: Undecided
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S