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
Qualifiers
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
Treatments tested in this trial
- Lu AH69593
- Placebo
Treatment groups
104 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov