HealthyPhase 1NCT02191189
Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract in Healthy Males
A Phase 1 study testing Nevirapine suspension, into Enterion™ capsule and Nevirapine suspension in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the absorption of Nevirapine from different regions of the Gastro Intestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nevirapine suspension, into Enterion™ capsule and Nevirapine suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jan 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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.
About this study
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 to determine the absorption of Nevirapine from different regions of the Gastro Intestinal tract.
- Conditions
- Healthy
- Being tested
- Nevirapine suspension, into Enterion™ capsule, Nevirapine suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine suspension, into Enterion™ capsuleDrug
Nevirapine suspensionDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A, p.o. | Active comparator | 50 mg Nevirapine administered orally in 100 mL water Receives: Drug: Nevirapine suspension |
| Treatment B, ascending colon | Experimental | 50 mg Nevirapine administered to the ascending colon via Enterion™ capsule Receives: Drug: Nevirapine suspension, into Enterion™ capsule |
| Treatment C, jejunum | Experimental | 50 mg Nevirapine administered to the jejunum via Enterion™ capsule Receives: Drug: Nevirapine suspension, into Enterion™ capsule |
| Treatment D, ileum | Experimental | 50 mg Nevirapine administered to the ileum via Enterion™ capsule Receives: Drug: Nevirapine suspension, into Enterion™ capsule |
| Treatment E, descending colon | Experimental | 50 mg Nevirapine administered to the descending colon via Enterion™ capsule Receives: Drug: Nevirapine suspension, into Enterion™ capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 72 hours after drug administration
Secondary outcomes (10)
Maximum measured concentration of nevirapine in plasma (Cmax)
Measured: up to 72 hours after drug administration
Time from dosing to the maximum concentration of nevirapine in plasma (tmax)
Measured: up to 72 hours after drug administration
Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 72 hours after drug administration
Terminal elimination rate constant of nevirapine concentration in plasma (λz)
Measured: up to 72 hours after drug administration
Terminal half-life of nevirapine in plasma (t1/2)
Measured: up to 72 hours after drug administration
Mean residence time of nevirapine in the body after oral administration (MRTpo)
Measured: up to 72 hours after drug administration
Apparent clearance of nevirapine in the plasma after extravascular administration (CL/F)
Measured: up to 72 hours after drug administration
Apparent volume of distribution during the terminal elimination phase following an extravascular dose (Vz/F)
Measured: up to 72 hours after drug administration
Number of patients with adverse events
Measured: up to 78 days
Assessment of tolerability by investigator
Measured: Days 1-4 of each treatment period and at the end-of-study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startMay 2005
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191189
- Sponsor's protocol ID
- 1100.1484
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02191189
- Acronym / sponsor ID
- 1100.1484
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jan 2006 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the absorption of Nevirapine from different regions of the Gastro Intestinal tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A, p.o. | Active comparator | Drug: Nevirapine suspension50 mg Nevirapine administered orally in 100 mL water |
| Treatment B, ascending colon | Experimental | Drug: Nevirapine suspension, into Enterion™ capsule50 mg Nevirapine administered to the ascending colon via Enterion™ capsule |
| Treatment C, jejunum | Experimental | Drug: Nevirapine suspension, into Enterion™ capsule50 mg Nevirapine administered to the jejunum via Enterion™ capsule |
| Treatment D, ileum | Experimental | Drug: Nevirapine suspension, into Enterion™ capsule50 mg Nevirapine administered to the ileum via Enterion™ capsule |
| Treatment E, descending colon | Experimental | Drug: Nevirapine suspension, into Enterion™ capsule50 mg Nevirapine administered to the descending colon via Enterion™ capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nevirapine suspension, into Enterion™ capsule | Drug | Treatment B, ascending colon, Treatment C, jejunum, Treatment D, ileum, Treatment E, descending colon |
| Nevirapine suspension | Drug | Treatment A, p.o. |
Primary outcome
Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 72 hours after drug administration
10 secondary outcomes
Maximum measured concentration of nevirapine in plasma (Cmax)
Time frame: up to 72 hours after drug administration
Time from dosing to the maximum concentration of nevirapine in plasma (tmax)
Time frame: up to 72 hours after drug administration
Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 72 hours after drug administration
Terminal elimination rate constant of nevirapine concentration in plasma (λz)
Time frame: up to 72 hours after drug administration
Terminal half-life of nevirapine in plasma (t1/2)
Time frame: up to 72 hours after drug administration
Mean residence time of nevirapine in the body after oral administration (MRTpo)
Time frame: up to 72 hours after drug administration
Apparent clearance of nevirapine in the plasma after extravascular administration (CL/F)
Time frame: up to 72 hours after drug administration
Apparent volume of distribution during the terminal elimination phase following an extravascular dose (Vz/F)
Time frame: up to 72 hours after drug administration
Number of patients with adverse events
Time frame: up to 78 days
Assessment of tolerability by investigator
Time frame: Days 1-4 of each treatment period and at the end-of-study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nevirapine suspension, into Enterion™ capsule and Nevirapine suspension in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: up to 72 hours after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.