Lu AH69593 in Healthy Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study investigates how Lu AH69593 is absorbed, distributed, metabolized, and excreted, and how it is affected by drug interactions with itraconazole, carbamazepine, and midazolam. Participants will receive Lu AH69593 alone and in combination with the other medicines in different parts of the study to see how co-administered drugs influence its pharmacokinetics and safety. The trial aims to characterize safety and tolerability in healthy adults and to identify potential drug–drug interaction effects. Inpatient monitoring is required from baseline through completion visits to ensure thorough safety assessment.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
* The participant is willing and able to attend trial appointments within the specified time windows.
* The participant is willing to be an inpatient from the Baseline Visit to the Completion Visit.

Key Exclusion Criteria:

* The participant has taken any investigational medicinal product (IMP) \<2 months or \<5 halflives of that product, whichever is longer, prior to the first dose of IMP.
* The participant has had, in the opinion of the investigator, a clinically significant illness from which he/she recovered \<4 weeks prior to the first dose of IMP.
* The participant has or has had, in the opinion of the investigator, any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* For Part B only: the participant tests positive for HLA-B\*15:02 or HLA-A\*31:01 allele. 3.
* For Part B only: the participant has a personal or family history of Stevens-Johnson syndrome or toxic epidermal necrolysis.

Additional protocol-defined criteria apply.

Where it's running

• Fortrea Clinical Research Unit Ltd (Labcorp Clinical Research Unit Limited)
  Madison, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing Lu AH69593 for safety and tolerance in healthy adults and people with narcolepsy

  This study tests whether Lu AH69593 is safe and well tolerated in adults, including those with narcolepsy, and looks at how the body processes the drug with and without food.

  Recruiting Phase 1 H. Lundbeck A/S · Helsinki and 1 other locations · NCT07613710

• Lu AF28996 addition for adults with Parkinson's and motor fluctuations

  This trial tests whether adding Lu AF28996 to optimized Parkinson's medications helps adults with motor fluctuations spend more time with controlled movement and less dyskinesia.

  Recruiting at 2 sites Phase 2 H. Lundbeck A/S · Farmington Hills, Michigan and 1 other locations · NCT07514858

• Lu AF28996 in people with Parkinson's disease

  This study tests whether Lu AF28996 is safe and tolerable for people with Parkinson's disease who have motor fluctuations.

  Recruiting at 4 sites Phase 1 H. Lundbeck A/S · Beijing, Beijing Municipality and 3 other locations · NCT07513441

• Eptinezumab for treating episodic migraine in children

  This study tests if a new medication called eptinezumab can help reduce the number of migraine days in children who have episodic migraines.

  Recruiting at 46 sites Phase 3 H. Lundbeck A/S · Stamford, Connecticut and 59 other locations · NCT05897320

• Evaluating Lu AG13909 for treating congenital adrenal hyperplasia

  This study is testing different doses of a new medication called Lu AG13909 to see if it can safely help adults with congenital adrenal hyperplasia manage their hormone levels better.

  Recruiting at 17 sites Phase 1/2 H. Lundbeck A/S · Ann Arbor, Michigan and 16 other locations · NCT05669950

• Long-term safety of eptinezumab for children and adolescents with migraines

  This study is testing the long-term safety of a migraine medication called eptinezumab in children and teens aged 6 to 17 who have chronic or episodic migraines.

  Recruiting at 54 sites Phase 3 H. Lundbeck A/S · New Haven, Connecticut and 63 other locations · NCT05164172

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.