A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects

NCT04976309 | Completed Phase 1

• 1 other identifier: 19734A
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of change from start of infusion in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38

  0 to 120 min after infusion

Secondary Outcomes (4)

• Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38

  0 to 60 min after infusion

• Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38

  0 and 120 min after infusion

• AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38

  0 to 120 min after infusion

• AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38

  0 to 120 min after infusion

Study Arms (3)

Placebo + saline

EXPERIMENTAL

Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Drug: Placebo

Placebo + VIP and PACAP

EXPERIMENTAL

Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Drug: Placebo

Lu AG09222 + VIP and PACAP

EXPERIMENTAL

Lu AG09222, single dose intravenous infusion over 30 minutes

Drug: Lu AG09222

Interventions

Lu AG09222 DRUG

Single dose

Lu AG09222 + VIP and PACAP

Placebo DRUG

Single dose

Placebo + VIP and PACAP; Placebo + saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject has a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit.
• The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening.

You may not qualify if:

• The subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the International Headache Society (IHS) International Classification of Headache Disorders 3rd edition (ICHD-3), except tension-type headache.
• The subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Danish Headache Center Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• Rasmussen NB, Deligianni C, Christensen CE, Karlsson WK, Al-Khazali HM, Van de Casteele T, Granhall C, Amin FM, Ashina M. The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study. J Headache Pain. 2023 May 25;24(1):60. doi: 10.1186/s10194-023-01599-w.

  PMID: 37231350 DERIVED

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 26, 2021
• Study Start: July 15, 2021
• Primary Completion: September 19, 2021
• Study Completion: December 10, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

DK (1)