Covance
Leeds, United Kingdom
NCT Number: NCT03670082
The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Leeds, United Kingdom
Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.
For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.
All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other inclusion and exclusion criteria may apply.
20 mg Lu AF35700 single oral dose
100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
Time frame: 0 to 120 hours
Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)
Time frame: 0 to 120 hours
Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700
Time frame: 0 to 120 hours
Maximum observed plasma concentration of Lu AF35700
Time frame: 0 to 120 hours
Time at which maximum observed plasma concentration of Lu AF35700 occurred
H. Lundbeck A/S
Industry
Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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