Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single- and Multiple-ascending-dose Trial Investigating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Participants, Including Open-label Cohorts to Explore Pharmacodynamic Properties in Participants With Narcolepsy, and Food Effect in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For all participants in any trial Part (A, B, C and D):
- •The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
- •Specifically for participants in trial Part A, B, and D:
- •The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) 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.
- •Specifically for participants in trial Part C:
- •The participant has a BMI ≥18.5 and ≤35 kg/m^2 at the Screening Visit.
- •The participant has NT1, diagnosed according to International Classification of Sleep Disorders, 3rd edition criteria, with a history of disease diagnosis >3 months prior to the Screening Visit.
- •The participant is ≥18 and ≤64 years of age at the Screening Visit.
Exclusion Criteria
- •For all participants in any trial Part (A, B, C and D):
- •The participant has previously been enrolled in this trial.
- •The participant has previously been dosed with Lu AH
- •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.
- •The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of investigational medicinal product (IMP).
- •The participant has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
- •The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.
- •Specifically for participants in trial Part A, B and D:
- •The participant has had a clinically significant illness from which he/she recovered <4 weeks prior to the first dose of IMP.
- •Specifically for Participants in trial Part B and C:
- •The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS answer of 'yes' to suicidal ideation question 4 or 5 or 'yes' to suicidal behaviour, within the last 6 months on the C-SSRS at the Screening Visit or 'Since last visit' at the Baseline Visit Day -
- •Specifically for participants in trial Part C:
- •The participant has any other disorder for which the treatment takes priority over treatment of narcolepsy or is likely to interfere with trial treatment or impair treatment compliance.
- •The participant has a current medical disorder, other than NT1, associated with excessive daytime sleepiness (EDS).
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
Arms & Interventions
Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive Lu AH69593 or placebo orally for 10 days.
Intervention: Placebo (Drug)
Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593
Participants will receive Lu AH69593 orally for 84 days.
Intervention: Lu AH69593 (Drug)
Part D (Food Effect in Healthy Participants): Lu AH69593
Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.
Intervention: Lu AH69593 (Drug)
Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive single oral dose of Lu AH69593 or placebo.
Intervention: Placebo (Drug)
Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive Lu AH69593 or placebo orally for 10 days.
Intervention: Lu AH69593 (Drug)
Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive single oral dose of Lu AH69593 or placebo.
Intervention: Lu AH69593 (Drug)
Outcomes
Primary Outcomes
PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Time Frame: Baseline, up to Day 11
Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline up to Day 90
Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
Time Frame: Up to 84 days
Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Time Frame: Up to 84 days
Time to Reach Cmax (Tmax) of Lu AH69593
Time Frame: Up to 84 days
AUC From Time Zero to Infinity (AUC0-inf)
Time Frame: Up to 6 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Day 90
Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Time Frame: Baseline up to Day 84
Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Time Frame: Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Omission
Time Frame: Baseline, up to Day 11
Secondary Outcomes
No secondary outcomes reported