Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00044707
First received: September 3, 2002
Last updated: May 20, 2015
Last verified: May 2015

September 3, 2002
May 20, 2015
August 2002
September 2002   (final data collection date for primary outcome measure)
To determine the effect of pramlintide on the PK of an oral medication [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

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
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Complete list of historical versions of study NCT00044707 on ClinicalTrials.gov Archive Site
safety and tolerability as measured by analysis of laboratory values and adverse events [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen).
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Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
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This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Pramlintide acetate
Clear, colorless, sterile solution for SC injection.
  • Active Comparator: Pramlintide acetate (AC137)
    Pramlintide 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
    Intervention: Drug: Pramlintide acetate
  • Placebo Comparator: Placebo
    Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2002
September 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus treated with diet and/or oral agents
  • HbA1c 6.5-11.0
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044707
137-154
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AstraZeneca
AstraZeneca
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AstraZeneca
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP