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Study · Not a test of the peptide alone · 2010

7 results

Semi-mechanistic population pharmacokinetic drug-drug interaction modelling of a long half-life substrate and itraconazole.

Lehr T, Staab A, Trommeshauser D, Schaefer HG, Kloft C

Clinical pharmacokinetics1 Jan 2010Cited by 15 (Europe PMC)

PMID20000889 (opens in a new tab)DOI10.2165/11317210-000000000-00000 (opens in a new tab)PepBankPUB-20000889
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone7

In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Tesofensine.

  1. 01HumanNot a test of Tesofensine aloneNon-randomized trialPharmacokinetics

    In subjects receiving tesofensine, itraconazole increased tesofensine exposure during coadministration by approximately 9% in non-compartmental analysis.

    In plain wordsIn subjects receiving tesofensine, itraconazole increased exposure during coadministration compared with tesofensine without itraconazole.

    Peptide
    Tesofensine
    Outcome
    IncreaseExposure during coadministration
    Study

    n: not reported in source

    Comparator
    Tesofensine without itraconazole
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Exposure increase
    ≈ 9%
    AUC from 0 to 144 hours, non-compartmental analysis

    Source sentences

    Summary
    using NCA, the actual study revealed an approximately 9% increase in exposure for the timeframe of the coadministration with itraconazole (the area under the plasma concentration-time curve (AUC) from 0 to 144 hours [AUC(144h)])
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

  2. 02HumanNot a test of Tesofensine aloneNon-randomized trialPharmacokinetics

    In subjects receiving tesofensine, itraconazole increased estimated exposure to infinity by approximately 26% in non-compartmental analysis.

    In plain wordsIn subjects receiving tesofensine, itraconazole increased the estimated total exposure compared with tesofensine without itraconazole.

    Peptide
    Tesofensine
    Outcome
    IncreaseExposure extrapolated to infinity
    Study

    n: not reported in source

    Comparator
    Tesofensine without itraconazole
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Exposure increase
    ≈ 26%
    AUC extrapolated to infinity, non-compartmental analysis

    Source sentences

    Summary
    and the impact on exposure estimated to infinity (AUC(infinity)) was approximately 26%.
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

  3. 03Computer modelNot a test of Tesofensine aloneIn silicoPharmacokinetics

    In a model of human pharmacokinetic data, tesofensine profiles followed a one-compartment model with itraconazole-inhibited first-order elimination.

    In plain wordsIn computer analysis, a one-compartment model described tesofensine concentrations and itraconazole inhibition of its elimination.

    Peptide
    Tesofensine
    Outcome
    Not applicableTesofensine concentration-time model
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    The plasma concentration-time profiles of itraconazole and tesofensine were best described by a one-compartment model for each drug, with first-order elimination rate constants that were both inhibited by itraconazole concentrations.
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

  4. 04Computer modelNot a test of Tesofensine aloneIn silicoPharmacokinetics

    In pharmacokinetic modeling, itraconazole inhibition reduced tesofensine clearance.

    In plain wordsIn computer analysis, itraconazole reduced modeled tesofensine clearance compared with tesofensine without itraconazole.

    Peptide
    Tesofensine
    Outcome
    DecreaseTesofensine clearance
    Study

    n: not reported in source

    Comparator
    Tesofensine without itraconazole
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    Inhibition resulted in reduced clearances and prolonged elimination half-lives for tesofensine and itraconazole:
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

  5. 05Computer modelNot a test of Tesofensine aloneIn silicoPharmacokinetics

    In pharmacokinetic modeling, itraconazole inhibition prolonged tesofensine elimination half-life.

    In plain wordsIn computer analysis, itraconazole prolonged modeled tesofensine elimination half-life compared with tesofensine without itraconazole.

    Peptide
    Tesofensine
    Outcome
    IncreaseTesofensine elimination half-life
    Study

    n: not reported in source

    Comparator
    Tesofensine without itraconazole
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    Inhibition resulted in reduced clearances and prolonged elimination half-lives for tesofensine and itraconazole:
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

  6. 06Computer modelNot a test of Tesofensine aloneIn silicoPharmacokinetics

    In a pharmacokinetic model, itraconazole reduced predicted tesofensine clearance by 38%.

    In plain wordsIn computer analysis, itraconazole reduced predicted tesofensine clearance compared with tesofensine without itraconazole.

    Peptide
    Tesofensine
    Outcome
    DecreasePredicted tesofensine clearance
    Study

    n: not reported in source

    Comparator
    Tesofensine without itraconazole
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Clearance reduction
    38%
    model prediction

    Source sentences

    Summary
    These results are in contrast to the model-predicted results, where the inhibitory effect of itraconazole caused a 38% reduction in the clearance of tesofensine, leading to a 63% increased exposure.
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

  7. 07Computer modelNot a test of Tesofensine aloneIn silicoPharmacokinetics

    In a pharmacokinetic model, itraconazole increased predicted tesofensine exposure by 63%.

    In plain wordsIn computer analysis, itraconazole increased predicted tesofensine exposure compared with tesofensine without itraconazole.

    Peptide
    Tesofensine
    Outcome
    IncreasePredicted tesofensine exposure
    Study

    n: not reported in source

    Comparator
    Tesofensine without itraconazole
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Exposure increase
    63%
    model prediction

    Source sentences

    Summary
    These results are in contrast to the model-predicted results, where the inhibitory effect of itraconazole caused a 38% reduction in the clearance of tesofensine, leading to a 63% increased exposure.
    1 context sentence
    Summary · context
    Overall, 28 subjects received a single oral dose of tesofensine 2 mg; 14 of these subjects were coadministered an oral itraconazole 400 mg loading dose and a 200 mg maintenance dose for 6 days before and 5 days after administration of tesofensine.

    In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    21 Oct 2026, 15:58 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 12:50 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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