NCT01324752

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1

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

March 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

March 25, 2011

Last Update Submit

December 19, 2012

Conditions

Drug Interaction Potentiation

Keywords

Drug-drug interactionPharmacokineticsPA21

Outcome Measures

Primary Outcomes (1)

  • Effect of PA21 on Losartan potassium

    To assess the effect, if any, of PA21 on Losartan potassium exposure

    PK assessment on Day 0, 11, 22

Secondary Outcomes (1)

  • Effect of PA21 on the active metabolite of Losartan potassium

    PK assessment on Day 0, 11, 22

Study Arms (3)

PA21 and Losartan with food

EXPERIMENTAL
Drug: PA21 and Losartan with Food

No PA21; Losartan with food

EXPERIMENTAL
Drug: No PA21; Losartan with food

PA21 with food and Losartan 2 hrs later

EXPERIMENTAL
Drug: PA21 with food and Losartan 2 hours later

Interventions

PA21 and Losartan with FoodDRUG

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.

PA21 and Losartan with food
No PA21; Losartan with foodDRUG

The maximum dose of Losartan will be 100 mg/day.

No PA21; Losartan with food
PA21 with food and Losartan 2 hours laterDRUG

The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.

PA21 with food and Losartan 2 hrs 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

LosartanFood

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDiet, 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

March 25, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

US(1)