An open-label, randomised, single-dose, three-way cross-over trial to assess the pharmacokinetics of NIC24-01 and NIC24-02 oromucosal pouches (a nicotine replacement therapy) in comparison to Nicorette® 4 mg gum in healthy adult smokers under fasted conditions.

Start 12 Dec 2024 · End 30 Jan 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 2024-CT-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 15

Countries 1

Sites 1

Nicotine dependence

Key facts

Sponsor: Niconovum AB
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
Trial duration: 12 Dec 2024 → 30 Jan 2025
Decision date (initial): 2024-11-21
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Nicotine dependence

Version	Level	Code	Term	System organ class
20.0	PT	10057852	Nicotine dependence	100000004873

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Niconovum AB

Sponsor organisation: Niconovum AB
Address: Hyllie Boulevard 32, Hyllie Hyllie
City: Malmo
Postcode: 215 32
Country: Sweden

Scientific contact point

Organisation: Niconovum AB
Contact name: Information desk

Public contact point

Organisation: Niconovum AB
Contact name: Information desk

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ended	15	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Ended

CTC Clinical Trial Consultants AB

CTC, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Sweden	2024-12-12	2025-01-30	2024-12-12	2025-01-30

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-09-06	Sweden	Acceptable 2024-11-20	2024-11-21