NCT04082325 is a Phase 1 clinical trial of Lu AF88434 in Healthy, sponsored by H. Lundbeck A/S.

Who is sponsoring NCT04082325?

NCT04082325 is sponsored by H. Lundbeck A/S.

What drugs are being tested in NCT04082325?

Interventions in NCT04082325: Lu AF88434, Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434), Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434), Placebo.

Is NCT04082325 still recruiting?

NCT04082325 is currently completed. Last updated 24 February 2021.

Last reviewed 2021-02-24 · How we verify

NCT04082325

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men

Completed Phase 1 Last updated 24 February 2021

What this trial tests

Phase 1 trial testing Lu AF88434 in Healthy in 68 participants. Completed in 24 September 2020.

Timeline

23 July 2019

Primary endpoint
24 September 2020

24 September 2020

Quick facts

Lead sponsor	H. Lundbeck A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	68
Start date	23 July 2019
Primary completion	24 September 2020
Estimated completion	24 September 2020
Sites	1 location across Netherlands

Drugs / interventions tested

Lu AF88434 — full drug profile →
Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) — full drug profile →
Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

H. Lundbeck A/S — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Progress in mechanistically novel treatments for schizophrenia.
Neef J, Palacios DS. · · 2021 · cited 5× · PMID 34671731 · DOI 10.1039/d1md00096a

Verify or expand the search:

Other trials of Lu AF88434

Trials testing the same drug.

NCT04538014 — A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other H. Lundbeck A/S trials

Trials by the same sponsor.

NCT07514858 — A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations · Phase 2 · not yet recruiting
NCT07513441 — A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) · Phase 1 · not yet recruiting
NCT06701526 — A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications · Phase 4 · active not recruiting
NCT06706622 — A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) · Phase 3 · active not recruiting
NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04082325 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lundbeck A/S
Last refreshed: 24 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04082325.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing