Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2002
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 3, 2002
CompletedFirst Posted
Study publicly available on registry
September 5, 2002
CompletedMay 21, 2015
May 1, 2015
1 month
September 3, 2002
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effect of pramlintide on the PK of an oral medication
To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax. t½: Terminal half-life The primary study endpoints include: * pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints * pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations
7 Days
Secondary Outcomes (1)
safety and tolerability as measured by analysis of laboratory values and adverse events
7 Days
Study Arms (2)
Pramlintide acetate (AC137)
ACTIVE COMPARATORPramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL
Placebo
PLACEBO COMPARATORPlacebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted
Interventions
Clear, colorless, sterile solution for SC injection.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus treated with diet and/or oral agents
- HbA1c 6.5-11.0
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
ICSL-Clinical Studies
Fort Lauderdale, Florida, 33301, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2002
First Posted
September 5, 2002
Study Start
August 1, 2002
Primary Completion
September 1, 2002
Study Completion
September 1, 2002
Last Updated
May 21, 2015
Record last verified: 2015-05