A Phase I Study to Evaluate the Safety and Tolerability of Lu AH70212 and Lu AH69593 in Healthy Adults for the Treatment of Narcolepsy

The primary objective of this study is to evaluate the safety and tolerability of Lu AH70212 and Lu AH69593 in healthy adults. Assessing these parameters is essential to determine the risk profile of the investigational products prior to clinical application in patients with narcolepsy.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 3 to 10 years. Both males and females are included in the study. The research pertains to individuals with narcolepsy.

This Phase 1 clinical trial is designed to evaluate the safety and tolerability of Lu AH70212 and Lu AH69593 in healthy adults. The study follows a controlled methodology to assess the pharmacological profile of the investigational products. The protocol begins with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor clinical responses, concluding with an end-of-study visit. The total duration of participation is determined by the specific sequence of scheduled assessments. Early termination from the study may occur based on predefined clinical criteria or safety protocols.

The assessment of efficacy in this phase 1 clinical trial for narcolepsy is not specified in the provided documentation. Information regarding efficacy endpoints, measurement schedules, or clinical instruments is unavailable.