Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
30
Countries
1
Sites
1
Autosomal Dominant Polycystic Kidney Disease
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 12 May 2026 → ongoing
- Decision date (initial)
- 2026-05-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Autosomal Dominant Polycystic Kidney Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036046 | Polycystic kidney autosomal dominant | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Temporarily halted | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-05-12 | 2026-05-18 | 2026-06-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-141802
- Halt date
- 2026-06-19
- Member states concerned
- Netherlands
- Publication date
- 2026-07-03
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- To review the cumulative safety database. To update the IB, protocol and ICF to include a new potential risk of elevated transaminases in blinded data.
- Follow-up measures
- Screening, randomisation and dosing of participants has been halted. Ongoing monitoring of participants who have been dosed in this single dose study is continuing, as per protocol. The updated IB, protocol, and ICF will be submitted to the relevant authorities as a substantial amendment, in accordance with local requirements.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-13 | Netherlands | Acceptable 2026-05-06
|
2026-05-06 |