A Study Investigating Lu AG06474 in Healthy Young Participants

Healthy Participants Clinical Trial

Official title:

Interventional, Randomized, Double-blind, Sequential Cohort, Placebo-controlled, Multiple-dose Trial Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 in Healthy Young Men and Women, With an Open-label, Cross-over, Single-dose Part Investigating the Relative Bioavailability of a Capsule Formulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943327
• Other study ID #: 20065A
• Status: Recruiting
• Phase: Phase 1
• Start date: June 28, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: August 2023
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.

Description:

The study has 2 parts: Part A and Part B.

Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo.

Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: August 15, 2024
• Est. primary completion date: August 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The participant has a body mass index (BMI) =18.5 and =30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Baseline Visit.

• The participant has a resting supine pulse =50 and =100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is =45 bpm.

• The participant has a resting supine systolic blood pressure =91 and =140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure =51 and =85 mmHg at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

• The participant has previously been dosed with Lu AG06474.

• The participant has participated in a clinical trial <30 days prior to the Screening Visit.

• The participant has taken any investigational medicinal product =30 days or <5 half-lives of that product, whichever is longer, prior to the first dose of IMP.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lu AG06474
Oral Solution
• Placebo
Oral Solution
• Lu AG06474
Capsule

Locations

Country	Name	City	State
United States	Quotient Sciences Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)		Up to Day 10
Primary	Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5		Day 5
Primary	Part A: AUC0-t: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval		Predose to Day 7
Primary	Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474		Predose to Day 6
Primary	Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax		Predose to Day 6
Primary	Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474		Predose to Day 6
Primary	Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity		Predose to Day 6
Primary	Part A: Accumulation Index		Predose to Day 7
Primary	Part B: Frel: Relative Bioavailability		Predose to Day 6