A Phase 1, Multi-Cohort, Open-Label, Randomized Pilot Study to Evaluate the Effect of Food and a Proton-Pump Inhibitor (esomeprazole) on the Single-Dose Pharmacokinetics of ARV-102 in Healthy Participants.

2025-523370-16-00 Protocol ARV-102-105 Human pharmacology (Phase I) - Other Ended

Start 17 Nov 2025 · End 23 Jan 2026 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol ARV-102-105

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 24
Countries 1
Sites 1

Parkinsonian syndromes

Key facts

Sponsor
Arvinas Operations Inc.
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
17 Nov 2025 → 23 Jan 2026
Decision date (initial)
2025-11-14
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Parkinsonian syndromes

VersionLevelCodeTermSystem organ class
20.0 HLT 10034005 Parkinson's disease and parkinsonism 10029205

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Arvinas Operations Inc.

Sponsor organisation
Arvinas Operations Inc.
Address
5 Science Park
City
New Haven
Postcode
06511-1966
Country
United States

Scientific contact point

Organisation
Arvinas Operations Inc.
Contact name
Clinical Trials NS

Public contact point

Organisation
Arvinas Operations Inc.
Contact name
Clinical Trials NS

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 24 1
Rest of world 0

Investigational sites

Netherlands

1 site · Ended
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 startTrial end Recruitment startRecruitment end Early termination
Netherlands 2025-11-17 2026-01-22 2025-11-21 2025-12-19

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-09-29 Netherlands Acceptable
2025-11-13
2025-11-14