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NCT02093169
Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
Phase 1 trial testing Part A: Lu AF35700 in Healthy Men in 12 participants. Completed.
1 June 2014
Quick facts
| Lead sponsor | H. Lundbeck A/S |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 February 2014 |
| Primary completion | 1 June 2014 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Part A: Lu AF35700 — full drug profile →
- Part B: Lu AF35700 — full drug profile →
Conditions studied
- Healthy Men — all drugs for Healthy Men →
Sponsor
H. Lundbeck A/S — full company profile →
Who can join
Adults 25 to 45, male only, with Healthy Men. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point
Time frame: Up to 172 hours after dosing -
Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point
Time frame: Up to 172 hours after dosing -
Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively
Time frame: Up to 172 hours after dosing
Sponsor's own description
To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02093169
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT02093169 (US National Library of Medicine, public domain)
- 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: 22 September 2014
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/NCT02093169.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing