An open-label, prospective, randomised, cross-over trial to assess the pharmacokinetics of an amorphous formulation of sorafenib in mesoporous magnesium carbonate (DPH001) compared to Nexavar® (sorafenib) in healthy volunteers

Start 30 Jan 2025 · End 10 Mar 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol DPH001-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 12

Countries 1

Sites 1

Hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma.

Key facts

Sponsor: Disruptive Pharma AB
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Not possible to specify
Trial duration: 30 Jan 2025 → 10 Mar 2025
Decision date (initial): 2025-01-15
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

Hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma.

Version	Level	Code	Term	System organ class
21.1	PT	10067946	Renal cell carcinoma	100000004864
21.1	LLT	10007476	Carcinoma thyroid	10029104
20.0	PT	10073071	Hepatocellular carcinoma	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Disruptive Pharma AB

Sponsor organisation: Disruptive Pharma AB
Address: Uppsala Science Park
City: Uppsala
Postcode: 751 83
Country: Sweden

Scientific contact point

Organisation: Disruptive Pharma AB
Contact name: Malin Vågerö, Director R&D

Public contact point

Organisation: Disruptive Pharma AB
Contact name: Peter Åsberg, CEO

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ended	12	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	2025-01-30	2025-03-10	2025-01-30	2025-03-10

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-10-29	Sweden	Acceptable 2025-01-09	2025-01-15