A Study to Learn How Different Forms of Study Medicine CTB-AVP Are Taken up Into the Blood and How It Is Taken up Into The Blood When Taken on An Empty Stomach or Taken With a Meal in Healthy Adults

Start 9 Jul 2024 · End 12 Oct 2024 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 12

Countries 1

Sites 1

Complicated urinary tract infection including pyelonephritis

Key facts

Sponsor: Pfizer Inc.
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trial duration: 9 Jul 2024 → 12 Oct 2024
Decision date (initial): 2023-10-10
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

Complicated urinary tract infection including pyelonephritis

Version	Level	Code	Term	System organ class
20.0	PT	10037596	Pyelonephritis	100000004862
20.0	PT	10046571	Urinary tract infection	100000004862

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation: Pfizer Inc.
Address: 66 Hudson Boulevard East
City: New York
Postcode: 10001-2189
Country: United States

Scientific contact point

Organisation: Pfizer Inc.
Contact name: Clinical Medical Lead

Public contact point

Organisation: Pfizer Inc.
Contact name: Clinical Medical Lead

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ended	12	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ended

Pfizer Clinical Research Unit

N/A, Lennikse Baan 808, 1070, Brussels

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
Belgium	2024-07-09	2024-10-11	2024-07-29	2024-09-09

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-08-29	Belgium	Acceptable 2023-10-10	2023-10-10
2	SUBSTANTIAL MODIFICATION	SM-1	2024-06-04	Belgium	Acceptable 2024-06-20	2024-07-03