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

NCT02253849 | Completed Phase 1

• 1 other identifier: 1182.80
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)

  up to 12 hours after drug administration

• Maximum measured concentration of Carbamazepine in plasma (Cmax)

  up to 12 hours after drug administration

• Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)

  up to 12 hours after drug administration

Secondary Outcomes (9)

• AUC0-12h

  up to 12 hours after drug administration

• Cmax

  up to 12 hours

• Cp12h

  up to 12 hours after drug administration

• Clearance (CL/F)

  up to 12 hours after drug administration

• Volume of distribution

  up to 12 hours after drug administration

Study Arms (1)

CBZ - TPB/r+CBZ

EXPERIMENTAL

Days 1-14: carbamazepine (CBZ) twice daily Days 15-22: CBZ twice daily plus TPV/r twice daily

Drug: Carbamazepine; Drug: Tipranavir; Drug: Ritonavir

Interventions

Carbamazepine DRUG

CBZ - TPB/r+CBZ

Tipranavir DRUG

CBZ - TPB/r+CBZ

Ritonavir DRUG

CBZ - TPB/r+CBZ

Eligibility Criteria

• Age: 20 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Carbamazepine; tipranavir; Ritonavir

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: November 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: October 1, 2014

Record last verified: 2014-09