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Tests treatment safety and results for Narcolepsy
Official title A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
ClinicalTrials.gov ID: NCT07613710
What this study is testing
What is Lu AH69593?
Lu AH69593 is an investigational medicine, being studied as a potential treatment for narcolepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Key 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...
- 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...
- The participant is ≥18 and ≤55 years of age at the Screening Visit. Specifically for participants in trial Part C:
You likely can't join if
- 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 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...
- The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical...
See the full eligibility criteria
- Key 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. Key
- 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 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Turku, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Turku, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.