HealthyPhase 1NCT02182336
Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
A Phase 1 study testing BI 201335 NA, Caffeine and Warfarin sodium in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this trial was to quantify the effect of oral single-dose (480 mg) and steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 201335 NA, Caffeine and Warfarin sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Sep 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
- Healthy males and female subjects age ≥18 to ≤55 years and according to the following criteria:
- Complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead EKG (electrocardiogram)(including determination of QTcB, and QtcF intervals), and clinical laboratory tests; all with acceptable findings
- Weighing at least 50 kg, and BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Volunteers must not leave the research unit, during the days of over-night stays, which include the periods from evening of Day-1 to morning of Day 5, and evening of Day 9 to morning of Day 24
- Volunteers must be willing to complete all study-related activities
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and EKG) deviating from normal and of clinical relevance, as assessed by the investigator
- Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, cancer, or bleeding disorders that require current medical treatment, may be unstable, or may be exacerbated by participation in the study
- Any evidence of a clinically relevant concomitant disease, which is not defined in the exclusion criteria 2 above, including but not limited to relevant chronic or acute infection
- Surgery of the gastrointestinal tract (except appendectomy and endoscopic removal of colon polyps)
- History or presence of allergy to any of the study drugs (e.g., BI 201335 NA, caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, digoxin, midazolam, omeprazole) or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Concomitant drugs, nutraceuticals, and herbal remedies that in the opinion of the investigator (in consultation with the BI medical monitor or pharmacokineticist), would interfere with either the absorption, distribution or metabolism of BI 201335 NA, or other study drugs
Show all 30Show fewer
- Use of drugs, which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 30 days prior to screening until trial completion
- Use of any investigational drug within 30 days prior to enrollment; or the planned usage of any investigational drug during the course of the current study
- Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to abstain from alcohol from day of screening to 7 days after last study drug administration.
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial
- Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator, and in consultation with the clinical monitor
- Known elevated liver enzymes in past with any compound (experimental or marketed)
- Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges, St. John's Wort
- Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin in addition to the studied warfarin dose, heparin, low-molecular weight heparin)
- Concomitant administration of oral contraceptives (may be included with 7-day washout period)
- Inadequate venous access
- Renal or hepatic insufficiency
- A marked baseline prolongation of QT/QTc interval e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms)
- Infection with hepatitis B (HBV), or hepatitis C virus (HCV), defined as either being hepatitis B surface antigen and /or hepatitis B core antibody positive, or hepatitis C antibody positive)
- Positive Enzyme-linked immunosorbent assay (ELISA) for Human Immunodeficiency Virus (HIV)-1 or HIV-2
- Fasting screening laboratory testing with direct bilirubin within the normal range and elevated total bilirubin, defined as 30% above the upper limit of normal
- For female subjects:
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test at screening visit
- No adequate contraception, e.g., sterilisation, IUD (intrauterine device), 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
- Lactation period with active breastfeeding from time of screening to 30 days after end of trial visit
About this study
Official title: Evaluation of the Effects of Single Oral Dose and Multiple Oral Doses of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail. An Open-label, Single-arm Phase I Study in Healthy Human Volunteers
The objective of this trial was to quantify the effect of oral single-dose (480 mg) and steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were assessed.
- Conditions
- Healthy
- Being tested
- BI 201335 NA, Caffeine, Warfarin sodium, Vitamin K, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 201335 NADrug
- 480 mg BI 201335 NA in the morning, 240 mg BI 201335 NA in the evening of day 10
- 240 mg BI 201335 NA bid from day 11 to 23
CaffeineDrug
days 1, 10 and 19
Warfarin sodiumDrug
days 1, 10 and 19
Vitamin KDrug
days 1, 10 and 19
OmeprazoleDrug
days 1, 10 and 19
Dextromethorphan hydrobromideDrug
days 1, 10 and 19
Midazolam HCl solutionDrug
Days 3 and 21
Midazolam HCl oral syrupDrug
days 1, 10 and 19
DigoxinDrug
Days 2 and 20
| Study group | Role | What they receive |
|---|---|---|
| BI 201335 NA | Experimental | Not described Receives: Drug: BI 201335 NA; Drug: Caffeine; Drug: Warfarin sodium; Drug: Vitamin K; Drug: Omeprazole; Drug: Dextromethorphan hydrobromide; Drug: Midazolam HCl solution; Drug: Midazolam HCl oral syrup; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) 0-24h of caffeine
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-120h of Warfarin
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours after treatment on days 1, 10 and 19
AUC0-24h of Omeprazole
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-24h of Dextromethorphan
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-24h of Midazolam IV
Measured: Pre-dose and 0.08, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after treatment on days 3 and 21
AUC0-24h of Midazolam oral
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-96h of Digoxin
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after treatment on days 2 and 20
Secondary outcomes (52)
AUC of caffeine
Measured: Baseline and day 1, day 1 and day 19
Cmax (Maximum Plasma Concentration after a single dose) of caffeine
Measured: Baseline and day 1, baseline and day 19
Ct (Plasma concentration at a given time t after a single dose) of caffeine
Measured: Baseline and day 1, baseline and day 19
tmax (Time of Maximum Concentration after a single dose) of caffeine
Measured: Baseline and day 1, baseline and day 19
CL/F (Oral Clearance after a single dose) of caffeine
Measured: Baseline and day1, baseline and day 19
t1/2 (Apparent Terminal Half-Life) of caffeine
Measured: Baseline and day 1, baseline and day 19
AUC of Warfarin
Measured: Baseline and day 1, day 1 and day 19
Cmax of Warfarin
Measured: Baseline and day 1, day 1 and day 19
Ct of Warfarin
Measured: Baseline and day 1, day 1 and day 19
tmax of Warfarin
Measured: Baseline and day 1, day 1 and day 19
CL/F of Warfarin
Measured: Baseline and day 1, day 1 and day 19
t1/2 of Warfarin
Measured: Baseline and day 1, day 1 and day 19
AUC of Omeprazole
Measured: Baseline and day 1, day 1 and day 19
Cmax of Omeprazole
Measured: Baseline and day 1, day 1 and day 19
Ct of Omeprazole
Measured: Baseline and day 1, day 1 and day 19
tmax of Omeprazole
Measured: Baseline and day 1, day 1 and day 19
CL/F of Omeprazole
Measured: Baseline and day 1, day 1 and day 19
t1/2 of Omeprazole
Measured: Baseline and day 1, day 1 and day 19
AUC of Dextromethorphan
Measured: Baseline and day 1, day 1 and day 19
Cmax of Dextromethorphan
Measured: Baseline and day 1, day 1 and day 19
Ct of Dextromethorphan
Measured: Baseline and day 1, day 1 and day 19
tmax of Dextromethorphan
Measured: Baseline and day 1, day 1 and day 19
CL/F of Dextromethorphan
Measured: Baseline and day 1, day 1 and day 19
t1/2 of Dextromethorphan
Measured: Baseline and day 1, day 1 and day 19
AUC of Midazolam IV
Measured: Baseline and day 1, day 1 and day 19
Cmax of Midazolam IV
Measured: Baseline and day 1, day 1 and day 19
Ct of Midazolam IV
Measured: Baseline and day 1, day 1 and day 19
tmax of Midazolam IV
Measured: Baseline and day 1, day 1 and day 19
CL/F of Midazolam IV
Measured: Baseline and day 1, day 1 and day 19
t1/2 of Midazolam IV
Measured: Baseline and day 1, day 1 and day 19
AUC of Midazolam oral
Measured: Baseline and day 1, baseline and day 19
Cmax of Midazolam oral
Measured: Baseline and day 1, baseline and day 19
Ct of Midazolam oral
Measured: Baseline and day 1, baseline and day 19
tmax of Midazolam oral
Measured: Baseline and day 1, baseline and day 19
CL/F of Midazolam oral
Measured: Baseline and day 1, baseline and day 19
t1/2 of Midazolam oral
Measured: Baseline and day 1, baseline and day 19
AUC of Digoxin
Measured: Baseline and day 1, baseline and day 19
Cmax of Digoxin
Measured: Baseline and day 1, baseline and day 19
Ct of Digoxin
Measured: Baseline and day 1, baseline and day 19
tmax of Digoxin
Measured: Baseline and day 1, baseline and day 19
CL/F of Digoxin
Measured: Baseline and day 1, baseline and day 19
t1/2 of Digoxin
Measured: Baseline and day 1, baseline and day 19
AUCτ,N (Uniform Dosing Interval τ Following the Nth Dose) of BI201335 NA
Measured: Day 10
AUCτ,ss,N of BI201335 NA
Measured: Day 19
Cmax,N of BI 201335 NA
Measured: Day 10
Cmax,ss,N of BI 201335 NA
Measured: Day 19
tmax,N of BI 201335 NA
Measured: Day 10
tmax,ss,N of BI 201335 NA
Measured: Day 19
Cmin,N of BI 201335 NA
Measured: Day 10
Cmin,ss,N of BI 201335 NA
Measured: Day 19
CL/F,ss,N of BI 201335 NA
Measured: Day 19
Urinary metabolic ratios of the analyte of first-day and steady state
Measured: up to day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2008
- Primary completionSep 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT02182336
- Sponsor's protocol ID
- 1220.32
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Single Oral Dose and Multiple Oral Doses of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail. An Open-label, Single-arm Phase I Study in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT02182336
- Acronym / sponsor ID
- 1220.32
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- First posted
- 8 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.
The objective of this trial was to quantify the effect of oral single-dose (480 mg) and steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 201335 NA | Experimental | Drug: BI 201335 NA, Drug: Caffeine, Drug: Warfarin sodium, Drug: Vitamin K, Drug: Omeprazole, Drug: Dextromethorphan hydrobromide, Drug: Midazolam HCl solution, Drug: Midazolam HCl oral syrup, Drug: Digoxin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
- Healthy males and female subjects age ≥18 to ≤55 years and according to the following criteria:
- Weighing at least 50 kg, and BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Volunteers must not leave the research unit, during the days of over-night stays, which include the periods from evening of Day-1 to morning of Day 5, and evening of Day 9 to morning of Day 24
- Volunteers must be willing to complete all study-related activities
Key exclusion criteria (30 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and EKG) deviating from normal and of clinical relevance, as assessed by the investigator
- Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, cancer, or bleeding disorders that require current medical treatment, may be unstable, or may be exacerbated by participation in the study
- Any evidence of a clinically relevant concomitant disease, which is not defined in the exclusion criteria 2 above, including but not limited to relevant chronic or acute infection
- Surgery of the gastrointestinal tract (except appendectomy and endoscopic removal of colon polyps)
- History or presence of allergy to any of the study drugs (e.g., BI 201335 NA, caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, digoxin, midazolam, omeprazole) or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
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 |
|---|---|---|
| BI 201335 NA1. 480 mg BI 201335 NA in the morning, 240 mg BI 201335 NA in the evening of day 10 2. 240 mg BI 201335 NA bid from day 11 to 23 | Drug | BI 201335 NA |
| Caffeinedays 1, 10 and 19 | Drug | BI 201335 NA |
| Warfarin sodiumdays 1, 10 and 19 | Drug | BI 201335 NA |
| Vitamin Kdays 1, 10 and 19 | Drug | BI 201335 NA |
| Omeprazoledays 1, 10 and 19 | Drug | BI 201335 NA |
| Dextromethorphan hydrobromidedays 1, 10 and 19 | Drug | BI 201335 NA |
| Midazolam HCl solutionDays 3 and 21 | Drug | BI 201335 NA |
| Midazolam HCl oral syrupdays 1, 10 and 19 | Drug | BI 201335 NA |
| DigoxinDays 2 and 20 | Drug | BI 201335 NA |
Primary outcome
Area under the curve (AUC) 0-24h of caffeine
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-120h of Warfarin
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours after treatment on days 1, 10 and 19
AUC0-24h of Omeprazole
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-24h of Dextromethorphan
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-24h of Midazolam IV
Time frame: Pre-dose and 0.08, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after treatment on days 3 and 21
AUC0-24h of Midazolam oral
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19
AUC0-96h of Digoxin
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours after treatment on days 2 and 20
52 secondary outcomes
AUC of caffeine
Time frame: Baseline and day 1, day 1 and day 19
Cmax (Maximum Plasma Concentration after a single dose) of caffeine
Time frame: Baseline and day 1, baseline and day 19
Ct (Plasma concentration at a given time t after a single dose) of caffeine
Time frame: Baseline and day 1, baseline and day 19
tmax (Time of Maximum Concentration after a single dose) of caffeine
Time frame: Baseline and day 1, baseline and day 19
CL/F (Oral Clearance after a single dose) of caffeine
Time frame: Baseline and day1, baseline and day 19
t1/2 (Apparent Terminal Half-Life) of caffeine
Time frame: Baseline and day 1, baseline and day 19
AUC of Warfarin
Time frame: Baseline and day 1, day 1 and day 19
Cmax of Warfarin
Time frame: Baseline and day 1, day 1 and day 19
Ct of Warfarin
Time frame: Baseline and day 1, day 1 and day 19
tmax of Warfarin
Time frame: Baseline and day 1, day 1 and day 19
CL/F of Warfarin
Time frame: Baseline and day 1, day 1 and day 19
t1/2 of Warfarin
Time frame: Baseline and day 1, day 1 and day 19
AUC of Omeprazole
Time frame: Baseline and day 1, day 1 and day 19
Cmax of Omeprazole
Time frame: Baseline and day 1, day 1 and day 19
Ct of Omeprazole
Time frame: Baseline and day 1, day 1 and day 19
tmax of Omeprazole
Time frame: Baseline and day 1, day 1 and day 19
CL/F of Omeprazole
Time frame: Baseline and day 1, day 1 and day 19
t1/2 of Omeprazole
Time frame: Baseline and day 1, day 1 and day 19
AUC of Dextromethorphan
Time frame: Baseline and day 1, day 1 and day 19
Cmax of Dextromethorphan
Time frame: Baseline and day 1, day 1 and day 19
Ct of Dextromethorphan
Time frame: Baseline and day 1, day 1 and day 19
tmax of Dextromethorphan
Time frame: Baseline and day 1, day 1 and day 19
CL/F of Dextromethorphan
Time frame: Baseline and day 1, day 1 and day 19
t1/2 of Dextromethorphan
Time frame: Baseline and day 1, day 1 and day 19
AUC of Midazolam IV
Time frame: Baseline and day 1, day 1 and day 19
Cmax of Midazolam IV
Time frame: Baseline and day 1, day 1 and day 19
Ct of Midazolam IV
Time frame: Baseline and day 1, day 1 and day 19
tmax of Midazolam IV
Time frame: Baseline and day 1, day 1 and day 19
CL/F of Midazolam IV
Time frame: Baseline and day 1, day 1 and day 19
t1/2 of Midazolam IV
Time frame: Baseline and day 1, day 1 and day 19
AUC of Midazolam oral
Time frame: Baseline and day 1, baseline and day 19
Cmax of Midazolam oral
Time frame: Baseline and day 1, baseline and day 19
Ct of Midazolam oral
Time frame: Baseline and day 1, baseline and day 19
tmax of Midazolam oral
Time frame: Baseline and day 1, baseline and day 19
CL/F of Midazolam oral
Time frame: Baseline and day 1, baseline and day 19
t1/2 of Midazolam oral
Time frame: Baseline and day 1, baseline and day 19
AUC of Digoxin
Time frame: Baseline and day 1, baseline and day 19
Cmax of Digoxin
Time frame: Baseline and day 1, baseline and day 19
Ct of Digoxin
Time frame: Baseline and day 1, baseline and day 19
tmax of Digoxin
Time frame: Baseline and day 1, baseline and day 19
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 18 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 BI 201335 NA, Caffeine and Warfarin sodium 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 30 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 18 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 curve (AUC) 0-24h of caffeine (time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours after treatment on days 1, 10 and 19). The study lists 7 primary outcomes in all. 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 18 Jul 2014.