NCT03916406 is a Phase 1 clinical trial of PF 06835919 in Healthy Volunteer, sponsored by Pfizer.

Who is sponsoring NCT03916406?

NCT03916406 is sponsored by Pfizer.

What drugs are being tested in NCT03916406?

Interventions in NCT03916406: PF 06835919, Midazolam.

What condition does NCT03916406 study?

NCT03916406 studies Healthy Volunteer.

Is NCT03916406 still recruiting?

NCT03916406 is currently completed. Last updated 16 July 2019.

Last reviewed 2019-07-16 · How we verify

NCT03916406

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS

Completed Phase 1 Last updated 16 July 2019

What this trial tests

Phase 1 trial testing PF 06835919 in Healthy Volunteer in 10 participants. Completed in 25 June 2019.

Timeline

18 April 2019

Primary endpoint
25 June 2019

25 June 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	10
Start date	18 April 2019
Primary completion	25 June 2019
Estimated completion	25 June 2019
Sites	1 location across Belgium

Drugs / interventions tested

PF 06835919
Midazolam (midazolam) — full drug profile →

Conditions studied

Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Study of the ketohexokinase inhibitor PF-06835919 as a clinical cytochrome P450 3A inducer: Integrated use of oral midazolam and liquid biopsy.
Qiu R, Fonseca K, Bergman A, Lin J, et al · · 2024 · cited 3× · PMID 38108609 · DOI 10.1111/cts.13644

Verify or expand the search:

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Other Pfizer trials

Trials by the same sponsor.

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NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03916406 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 16 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03916406.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing