Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: PlaceboDrug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
- Registration Number
- NCT04082325
- Lead Sponsor
- H. Lundbeck A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A Lu AF88434 or Placebo 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 Part A Lu AF88434 or Placebo Lu AF88434 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 Part B2 Lu AF88434 Fasting-Fed-Fasting Lu AF99722 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. Part B1 Lu AF88434 Fed-Fasting-Fasting Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) 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. Part B2 Lu AF88434 Fasting-Fed-Fasting 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. Part B1 Lu AF88434 Fed-Fasting-Fasting Lu AF88434 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. Part B3 Lu AF88434 Fasting-Fasting-Fed 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.
- Primary Outcome Measures
Name Time Method Cmax Lu AF88434 From 0 to 96 hours Maximum observed plasma concentration
CL/F Lu AF88434 From day 1 to day 5 Oral clearance for Lu AF88434 in plasma
Number of participants with treatment-emergent adverse events 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) From 0 to Day 14 Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) From 0 to Day 14 AUC(0-inf) Lu AF88434 From 0 to 96 hours Area under the plasma concentration time curve from zero to infinity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QPS
🇳🇱Groningen, Netherlands