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Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract in Healthy Males

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Nevirapine suspension, into Enterion™ capsule (Drug); Nevirapine suspension (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Study to determine the absorption of Nevirapine from different regions of the Gastro Intestinal tract.

Clinical Details

Official title: A Single-dose, 2-part, Open-label, Randomised, Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Secondary outcome:

Maximum measured concentration of nevirapine in plasma (Cmax)

Time from dosing to the maximum concentration of nevirapine in plasma (tmax)

Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Terminal elimination rate constant of nevirapine concentration in plasma (λz)

Terminal half-life of nevirapine in plasma (t1/2)

Mean residence time of nevirapine in the body after oral administration (MRTpo)

Apparent clearance of nevirapine in the plasma after extravascular administration (CL/F)

Apparent volume of distribution during the terminal elimination phase following an extravascular dose (Vz/F)

Number of patients with adverse events

Assessment of tolerability by investigator

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy males according to the following criteria: complete medical history,

including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

- Aged 18-65 years

- Body Mass Index of between 18 and 35 kg/m2

- Subjects must be able to demonstrate ability to swallow an empty size 000 gelatin

capsule

- Must be willing and able to participate in the whole study

- Must be able to provide signed and dated written informed consent prior to admission

to the study in accordance with Good Clinical Practice and the local legislation Exclusion Criteria:

- Participation in a clinical research study involving investigational drugs or dosage

forms within the previous 3 months

- Those who are unable/unwilling to consume all the components of a standard meal or

gelatine

- Subjects who have ever self referred or who have been referred to a physician or

counsellor for abuse or misuse of alcohol, non-medical, medicinal drugs or other substance abuse e. g. solvents

- Any current or previous use of Class A drugs such as opiates, cocaine, ecstasy,

lysergic acid diethylamide (LSD), and amphetamines (Class B unless prepared for injection, in which case amphetamines are Class A)

- Volunteers that admit to occasional past use of cannabis will not be excluded as long

as they have a negative drugs of abuse test and have been abstinent for at least 12 months

- Positive drugs of abuse test result

- Regular alcohol consumption in males >= 21 units per week. (1 Unit = ½ pint beer, a

25 mL shot of 40% spirit or a 125 mL glass of wine)

- Smoking of more than 10 cigarettes per day or equivalent (e. g. pipe, cigar, chewing

tobacco)

- A breath carbon monoxide reading of greater than 20 ppm

- Inability to refrain from smoking for the duration of each study period

- Radiation exposure from clinical trials, including that from the present study and

from diagnostic X-rays but excluding background radiation, exceeding 5 Millisieverts (mSv) in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study

- Clinically significant abnormal biochemistry, haematology or urinalysis, as judged by

the Investigator

- Liver function laboratory test (LFT) results outside the upper normal range. Subjects

with LFTs > grade 1 will not be included

- History of gastrointestinal surgery, with the exception of appendicectomy unless it

was performed within the previous 12 months

- History of clinically significant cardiovascular, renal, hepatic, respiratory and

particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome

- History of chronic or acute infections

- Diseases of the central nervous system (such as epilepsy) and psychiatric or

neurological disorders

- Acute diarrhoea or constipation in the 7 days before the predicted first study day.

If screening occurs >14 days before first study day, this criterion to be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day

- Donation of blood within the previous three months

- Presence of non-removable metal objects such as metal plates, screws etc, in the

abdominal region of the body

- Subjects will be excluded from the study if they are considered by the investigator

to be at risk of transmitting through blood and other body fluids the agents responsible for AIDS (Acquired Immunodeficiency Syndrome) or other sexually transmitted disease or hepatitis. This will be achieved by the use of a card (similar to that used by the National Blood Transfusion Service), which asks a potential subject if they have reason to believe that they may fall into any category included on the card. If the verbal answer is in the affirmative then they will be excluded from the study.

- Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV test results

- Subjects receiving prohibited medication. Subjects must not stop taking a prescribed

medication for the purpose of entering the study.

- Failure to satisfy the Principal Medical Investigator of fitness to participate for

any other reason As a precaution, male subjects will be instructed to use appropriate barrier method contraception (e. g. condoms and spermicide) during the time interval between taking the first dose and three months following the last dose. Subjects will be advised to inform Pharmaceutical Profiles if their partner becomes pregnant within three months of them receiving the last dose of the study drug. Pharmaceutical Profiles will monitor the pregnancy to conclusion.

Locations and Contacts

Additional Information

Starting date: May 2005
Last updated: July 15, 2014

Page last updated: August 23, 2015

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