PPI And Food Effect Study For PF-06463922 In Healthy Volunteers

NCT02569554 | Completed Phase 1

• 3 other identifiers: B74610082015-003416-21PPI STUDY
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will be conducted in healthy adult subjects to evaluate the effect of proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the bioavailability of the oral solution relative to the tablet formulation of PF-06463922.

Conditions

Healthy

Keywords

PF-06463922; rabeprazole; proton pump inhibitor (PPI); pharmacokinetics(PK); food effect

Outcome Measures

Primary Outcomes (2)

• plasma AUCinf for PF-06463922

  area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922

  3 months

• plasma Cmax for PF-06463922

  observed maximal plasma PF-06463922 concentration

  3 months

Secondary Outcomes (5)

• plasma AUClast for PF-06463922

  3 months

• plasma Tmax for PF-06463922

  3 months

• plasma t1/2 for PF-06463922

  3 months

• plasma CL/F for PF-06463922

  3 months

• plasma Vz/F for PF-06463922

  3 months

Study Arms (1)

PF-06463922

EXPERIMENTAL

each subject will receive four single doses of PF-06463922 without food, with food, with rabeprazole (without food), and one of the two new formulations without food.

Drug: PF-06463922; Drug: rabeprazole

Interventions

PF-06463922 DRUG

each subject will receive 4 single oral doses of 100 mg PF-06463922 (treatment A: tablets without food; treatment B: tablets with food; treatment C: tablets without food with rabeprazole; treatment D: oral solution without food). There will be at least 10 days washout period between consecutive PF-06463922 single dose.

PF-06463922

rabeprazole DRUG

20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.

Also known as: Pariet

PF-06463922

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects of non-childbearing potential and/or male subjects
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document.
• Subject must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular
• Any condition possibly affecting drug absorption
• A positive urine drug screen.
• Use of tobacco- or nicotine containing products within 90 days of screening or a positive urine cotinine test and history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of Screening.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

lorlatinib; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

BE (1)