Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Properties of Lu AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Cmax Lu AF88434
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •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.
- •For Part B: The subject has received radiolabelled material <12 months prior to the Screening Visit.
- •Other inclusion and exclusion criteria may apply
Arms & Interventions
Part A Lu AF88434 or Placebo
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
Intervention: Lu AF88434 (Drug)
Part A Lu AF88434 or Placebo
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
Intervention: Placebo (Drug)
Part B1 Lu AF88434 Fed-Fasting-Fasting
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.
Intervention: Lu AF88434 (Drug)
Part B1 Lu AF88434 Fed-Fasting-Fasting
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.
Intervention: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) (Drug)
Part B2 Lu AF88434 Fasting-Fed-Fasting
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.
Intervention: Lu AF88434 (Drug)
Part B2 Lu AF88434 Fasting-Fed-Fasting
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.
Intervention: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) (Drug)
Part B3 Lu AF88434 Fasting-Fasting-Fed
4 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed.
Intervention: Lu AF88434 (Drug)
Outcomes
Primary Outcomes
Cmax Lu AF88434
Time Frame: From 0 to 96 hours
Maximum observed plasma concentration
Number of participants with treatment-emergent adverse events
Time Frame: From screening to Day 11
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters)
Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Time Frame: From 0 to Day 14
AUC(0-inf) Lu AF88434
Time Frame: From 0 to 96 hours
Area under the plasma concentration time curve from zero to infinity
CL/F Lu AF88434
Time Frame: From day 1 to day 5
Oral clearance for Lu AF88434 in plasma
Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Time Frame: From 0 to Day 14
Secondary Outcomes
No secondary outcomes reported