NCT05201092

Brief Summary

The purpose of this study is to investigate how the drug Lu AG06466 is absorbed, metabolized, and excreted from the body, for example, what the body does to the drug after swallowing a single dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

January 7, 2022

Last Update Submit

March 15, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (11)

  • Cumulative Percent Recovery of Radioactivity in Urine

    From Day 1 to Day 23

  • Cumulative Percent Recovery of Radioactivity in Faeces

    From Day 1 to Day 23

  • Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces

    From Day 1 to Day 23

  • Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AG06466

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • AUC0-inf of Metabolite Lu AG06988 in Plasma

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • Cmax of Metabolite Lu AG0988 in Plasma

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • Time to Reach Cmax (tmax) of Lu AG06466

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • Tmax of Metabolite Lu AG06988

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

  • t1/2 of Metabolite Lu AG06988 in Plasma

    0 (predose) up to 96 hours postdose on Day 1 to Day 5

Study Arms (1)

[14C]-Lu AG06466

EXPERIMENTAL

Participants will receive a single oral dose of \[14C\]-Lu AG06466 on Day 1 in the fed state.

Drug: [14C]-Lu AG06466

Interventions

[14C]-Lu AG06466DRUG

\[14C\]-Lu AG06466 will be administered per schedule specified in the arm description.

[14C]-Lu AG06466

Eligibility Criteria

Age45 Years - 60 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m\^2) and a body weight of ≥60 kg at the Screening Visit and at the Baseline Visit.
  • 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.
  • The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

You may not qualify if:

  • The participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives prior to the Screening Visit for any medication taken.
  • The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 mmHg or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Baseline Visit.
  • The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
  • The participant has received a COVID-19 vaccination less than 30 days prior to the first dose of study drug.
  • The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.
  • The participant is exposed to significant levels of ionizing radiation at work.
  • The participant has undergone any clinical procedures involving significant exposure to radiation (excluding dental X-ray and common X-rays of the chest or extremities) \<12 months prior to the Screening Visit.
  • The participant has received radiolabelled material \<12 months prior to the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LabCorp Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 21, 2022

Study Start

January 5, 2022

Primary Completion

February 19, 2022

Study Completion

February 19, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

GB(1)