Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005849

Trial Description

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Title

Effects of Genetic Polymorphisms in the Organic Cation Transporter OCT1 on Cellular Uptake and Metabolism of Antidepressants and Other Organic Cationic Drugs

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Trial Acronym

PG-OCT

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine the effect of the organic cation transporter OCT1
polymorphisms on the pharmacokinetics of several drugs in order to explain efficacy and
adverse effects.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005849
  •   2014/06/16
  •   2014/01/30
  •   yes
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Secondary IDs

  •   2012-003546-33 
  •   NCT02054299  (ClinicalTrials.gov)
  •   PG-OCT  (University Medical Center Goettingen)
  •   2012-003546-33 
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Health Condition or Problem studied

  •   Drug Metabolism
  •   Membrane Transport
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Interventions/Observational Groups

  •   Drug: Drug application Amitriptyline
  •   Drug: Drug application Desvenlafaxine
  •   Drug: Drug application Sumatriptan
  •   Drug: Drug application Proguanil
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   I
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Primary Outcome

- Area under the plasma concentration-time curve (AUC) of the investigational drugs; time frame: up to 60 hours

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Secondary Outcome

- Total clearance, Cmax, Tmax, Mean AbsorptionTime, Alpha and Beta half-lives, Mean Residence Time (MRT) and Volume of distribution of the investigated drugs and their metabolites; time frame: up to 60 hours
- Dry mouth, fatigue, nausea, headache, vertigo, tinnitus, chills, anxiety and difficulties to read on Visual Analog Scales.; time frame: up to 60 hours
- Sedation on Stanford sedation scale; time frame: up to 60 hours
- Pupil diameter, latency, diameter at maximal constriction, amplitude and time for 33% recovery of initial pupil diameter measured by pupillometrie; time frame: up to 60 hours
- Genetic variants in OCT1, CYP2C19, CYP2D6 and MAO A; time frame: Baseline

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/04/30
  •   35
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

1. Written informed consent obtained prior to study entry including informed consent for
molecular genetic analysis concerning candidate genes relevant for pharmacokinetics
and pharmacodynamics of the study medication.

2. Both genders (male and female), as far as feasible, in each of the 3 OCT1 genotype
groups, an equal proportion of males and females will be included.

3. Healthy adults aged ≥18 to < 50 years

4. Body weight not less than 48 kg and body mass index (BMI) not less than 17 kg/m² and
not greater than 32 kg/m².

5. Willingness to meet the study instructions and to co-operate with the study personal

6. No clinically relevant pathological findings in any of the investigations at the
screening visit. Minor deviations of laboratory values from the normal range may be
accepted, if judged by the investigator to have no clinical relevance

7. Systolic blood pressure ≤ 140 mmHg and ≥ 100 mmHg, diastolic blood pressure ≤ 90 mmHg
and ≥ 60 mmHg and heart rate ≤ 90 bpm and ≥ 50 bpm at screening visit

8. Female subjects will only be included if they express their willingness not to become
pregnant during the entire study period by practicing abstinence or reliable methods
of contraception as specified in the respective protocol section.

9. Nonsmokers

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Exclusion Criteria

1. Unwillingness or inability to give informed consent

2. Involvement in the planning and conduct of the study (applies to staff directly
employed at the study site / department)

3. Participation in a clinical study or use of any other investigational or
non-registered drug or vaccine during the study period or within 30 days preceding
the first dose of study drugs.

4. Blood, plasma or thrombocyte donation during the last 15 days prior to application of
the test drugs.

5. Any planned surgical treatment during the last 14 days prior and 14 days after the
application of the test drugs.

6. Known pregnancy or lactation period

7. Any relevant pathological findings in any of the investigations at the screening
visit including significant abnormalities as result of the
medical-screening-laboratory-analysis, especially of the liver and kidney related
parameters unless judged as medically irrelevant.

8. QTcF > 450 ms in screening ECG

9. Systolic blood pressure > 140 mmHg and < 100 mmHg, diastolic blood pressure > 90 mmHg
and < 60 mmHg and heart rate > 90 bpm and < 50 bpm pre-dose at treatment period 4
(Amitriptyline)

10. Any disease affecting liver or kidney or impairment of the liver or kidney-function

11. Any cardiovascular disease

12. Moderate to severe hypertension requiring medication therapy

13. Bronchogenic asthma requiring constant drug treatment (stages 2 to 4 asthma)

14. Diabetes mellitus, hyperthyroidism, hypothyroidism

15. Glaucoma

16. Symptomatic prostatic hyperplasia

17. Any medical constellation that increases risk of bleeding, including chronic
treatment with NSAID or COX-2 inhibitors

18. History of alcohol and/or drug abuse and/or any abusive use of medicaments and/or
positive drug screen

19. History of any psychiatric or neurologic disorder. If there are any doubts at the
screening visit on whether a person is suffering from a depression or not he or she
will be excluded from the study or examined by a psychiatrist for clarification
before inclusion.

20. Any major gastrointestinal disease and any gastrointestinal disorder that is expected
to significantly interfere with the pharmacokinetics of the study drug

21. Gastrointestinal surgery which may interfere with the pharmacokinetics of the study
drug (except appendectomy or herniotomy)

22. Taking any medication within 7 days before or during the trial with the following
exceptions: Oral contraceptive drug used will be documented but will not be an
exclusion criterion. Other medication might be allowed on single case basis if
considered necessary for the subject's safety and well-being and if interactions with
the study medication are judged as irrelevant.

23. Any other findings that could compromise the safety of the participant or the quality
of the study-results

24. Any known hypersensitivity or allergic reactions to any of the tested drugs

25. History of severe hypersensitivity reactions and anaphylaxis

26. Any other clinically significant diseases as judged by the investigator

27. Body temperature > 37.5°C prior to drug application

28. Known infection with HIV, Hepatitis B (HBsAg) or Hepatitis C (no laboratory
diagnostics concerning these diseases will be performed within the present study)

29. Inability or unwillingness to avoid any intake of alcohol from 48 h prior to until 72
hours after Investigational Medicinal Product (IMP) application application

30. Pregnancy (positive pregnancy test performed prior to drug administration)

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Addresses

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    • University Medical Center Goettingen
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    • University Medical Center Goettingen
    • Juergen Brockmoeller, Prof. 
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    • Juergen Brockmoeller, Prof. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.