NCT01438359

Brief Summary

The purpose of this study is to determine if Furosemide is affected by PA21.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2011

Enrollment Period

2 months

First QC Date

September 16, 2011

Last Update Submit

September 29, 2011

Conditions

Healthy

Keywords

Drug-drug interactionPharmacokineticsPA21Drug Interaction Potentiation

Outcome Measures

Primary Outcomes (1)

  • Effect of PA21 on Furosemide

    To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).

    PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose

Study Arms (3)

PA21 and Furosemide with food

EXPERIMENTAL
Drug: PA21 and Furosemide with food

No PA21; Furosemide with food

EXPERIMENTAL
Drug: No PA21; Furosemide with food

PA21 with food and Furosemide 2hrs later

EXPERIMENTAL
Drug: PA21 with food and Furosemide 2hrs later

Interventions

PA21 and Furosemide with foodDRUG

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day

PA21 and Furosemide with food
No PA21; Furosemide with foodDRUG

The maximum dosage of Furosemide will be 40 mg/day

No PA21; Furosemide with food
PA21 with food and Furosemide 2hrs laterDRUG

The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day

PA21 with food and Furosemide 2hrs later

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Written informed consent

You may not qualify if:

  • No significant medical conditions
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACRI - Phase 1

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

FurosemideFood

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Peter J Winkle, MD

    ACRI - Phase 1 (Advanced Clinical Research Institute)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 22, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 30, 2011

Record last verified: 2011-09

Locations

US(1)