A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
ConditionNarcolepsy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorH. Lundbeck A/S
About this trial
The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m²) at the Screening Visit.
The participant has a normal circadian rhythm, defined as a person who usually wakes up between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.
The participant is ≥18 and ≤55 years of age at the Screening Visit.
Disqualifiers
The participant has previously been enrolled in this trial.
The participant has previously been dosed with Lu AH69593.
The participant has participated in a clinical trial <30 days prior to the Screening Visit.
The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
Trial design
Design model
Sequential
Treatments tested in this trial
Lu AH69593
DrugLu AH69593 will be administered per schedule specified in the arm description.
Placebo
DrugPlacebo will be administered per schedule specified in the arm description.
Treatment groups
104 Participants
are divided into 4 treatment groupsGroup A: Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or PlaceboExperimental treatment 2 interventions
Group B: Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or PlaceboExperimental treatment 2 interventions
Group C: Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593Experimental treatment 1 intervention
Group D: Part D (Food Effect in Healthy Participants): Lu AH69593Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame
Baseline up to Day 902
Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Time frame
Baseline up to Day 843
Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Time frame
Baseline, up to Day 114
PVT Parameter - Change From Baseline in Number of Errors of Omission
Time frame
Baseline, up to Day 11Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov