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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Ritonavir

Drug: Tipranavir

Drug: Carbamazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02253849

1182.80

Details and patient eligibility

About

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)

Enrollment

28 patients

Sex

All

Ages

20 to 58 years old

Volunteers

Accepts Healthy Volunteers

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