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Trial record 18 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02253849
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily)

Condition or disease Intervention/treatment Phase
Healthy Drug: Carbamazepine Drug: Tipranavir Drug: Ritonavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Centre, Open-label Study With Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r 500/200 mg on the Steady-state Pharmacokinetics of Carbamazepine (200 mg Twice Daily)
Study Start Date : November 2005
Actual Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CBZ - TPB/r+CBZ

Days 1-14: carbamazepine (CBZ) twice daily

Days 15-22: CBZ twice daily plus TPV/r twice daily

Drug: Carbamazepine
Drug: Tipranavir
Drug: Ritonavir

Primary Outcome Measures :
  1. Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h) [ Time Frame: up to 12 hours after drug administration ]
  2. Maximum measured concentration of Carbamazepine in plasma (Cmax) [ Time Frame: up to 12 hours after drug administration ]
  3. Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h) [ Time Frame: up to 12 hours after drug administration ]

Secondary Outcome Measures :
  1. AUC0-12h [ Time Frame: up to 12 hours after drug administration ]
  2. Cmax [ Time Frame: up to 12 hours ]
  3. Cp12h [ Time Frame: up to 12 hours after drug administration ]
  4. Clearance (CL/F) [ Time Frame: up to 12 hours after drug administration ]
  5. Volume of distribution [ Time Frame: up to 12 hours after drug administration ]
  6. Time from dosing to the maximum concentration (Tmax) [ Time Frame: up to 12 hours after drug administration ]
  7. t1/2 (terminal elimination half-life) [ Time Frame: up to 12 hours after drug administration ]
  8. Number of subjects with adverse events [ Time Frame: up to 35 days ]
  9. Number of subjects with clinically relevant changes in laboratory parameters [ Time Frame: up to 35 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male and non-pregnant, non-lactating female subjects as determined by results of screening
  • Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
  • Age >19 and <59 years
  • Weight ≥ 60 kg
  • BMI >18.5 and <35 kg/m2
  • Ability to maintain adequate contraception if applicable

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
  • AV block including 1°
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • Relevant history of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Known hypersensitivity to TPV, Ritonavir (RTV), carbamazepine or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
  • Known elevated liver enzymes in past trials with any compound
  • Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration or during the trial)
  • Prescription or over the counter medications (including vitamins, minerals, herbal supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial)
  • Participation in another trial with an investigational drug (<2 months prior to administration or expected during trial)
  • Smoker with a consumption of >10 cigarettes or >3 cigars or >3 pipes/day and those who cannot keep tobacco intake constant
  • Alcohol abuse (>60 g/day)
  • Drug abuse
  • Blood donation or loss >400 mL, <1 month prior to administration or expected during the trial
  • Clinically relevant laboratory abnormalities
  • Inability to comply with dietary regimen of study centre

For female subjects:

  • Pregnancy or planning to become pregnant within 60 days of study completion
  • Positive pregnancy test
  • Have not been using a barrier method of contraception for at least 3 months prior to participation in the study
  • Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
  • Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
  • Breast-feeding

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02253849    
Other Study ID Numbers: 1182.80
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators