HealthyPhase 1NCT01647256
Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions
A Phase 1 study testing Nikkomycin Z in people with Healthy, run by University of Arizona at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nikkomycin Z
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be at least 18 years of age and not over 40 years of age
- Be male, or female (non childbearing potential or using adequate contraception)
- Have a body mass index between 18 and 29 kg/m2
- Able to understand the study and give written informed consent
- Be determined healthy based on a medical and laboratory evaluation
Who cannot join
- Patients under the age of 18 years or over 40 years of age
- Current smoker or history of smoking within 3 months of participation
- Inability to comprehend study and provide written informed consent
- Inability to comply with the study requirements
- History of or current evidence of major organ disease
- Renal disease - serum creatinine > 1.5 mg/dL, significant hematuria or proteinuria, known structural abnormality or chronic kidney disease
Show all 18Show fewer
- Hepatic disease - active viral hepatitis, history of hepatitis B or hepatitis C, bilirubin > 2.0, ALT or AST above normal upper limit for laboratory, alcoholic liver disease, other chronic liver disease
- CNS disease or cognitive dysfunction - any past history of epilepsy, CNS infections, stroke, CNS bleed, severe headaches, major psychiatric illness, or current mental status changes
- Lung disease - history of severe asthma, COPD, pulmonary tuberculosis, or other major lung disease
- Cardiac disease - history or current evidence of ischemic coronary artery disease, myocardial infarction, heart failure, or significant arrhythmia
- Gastrointestinal disease - presence of inflammatory bowel disease, difficulty swallowing, or any gastrointestinal probably that would limit taking oral medications or that may compromise absorption of oral medications
- Cancer - History of hematologic malignancy or solid tumor excluding basal cell carcinoma limited to the skin within the past 5 years
- History of autoimmune or inflammatory disease such as rheumatoid arthritis and lupus
- Immunocompromised state - solid organ transplant, cancer chemotherapy, stem cell transplant with graft versus host disease, immunosuppressive therapy, or HIV infection
- Recent weight loss of greater than 10%
- Any other history or evidence of disease that in the opinion of the physician would increase the risk for the subject for clinical trial participation
- Regular use of prescription medications, over-the-counter medications, or dietary/herbal supplements within 14 days of day 1. Occasional use of acetaminophen or over-the-counter NSAID within the 14 day window may be allowed at the P.I. discretion
- Subjects who received another investigational drug within 30 days of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona - Clinical and Translational Science Research Center
Tucson, Arizona, 85724
About this study
Official title: Comparison of Nikkomycin Z Bioavailability After Single Dose Administration Under Fed (High Fat Meal) Compared to Fasting Conditions
The primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.
Read the detailed description
To compare the single-dose bioavailability of Nikkomycin Z 500 mg (two 250 mg capsules) under fed and fasting conditions.
- Conditions
- Healthy
- Being tested
- Nikkomycin Z
- Keywords
- Bioavailability, Fed, Fasting
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nikkomycin ZDrug
Capsule, 500 mg, single-dose
| Study group | Role | What they receive |
|---|---|---|
| Nikkomycin Z fed - fasting | Experimental | Period 1:
* Day 1: Nikkomycin Z 500 mg with high fat breakfast
Period 2:
* Day 1: Nikkomycin Z 500 mg under fasted conditions Receives: Drug: Nikkomycin Z |
| Nikkomycin Z fasting - fed | Experimental | Period 1:
* Day 1: Nikkomycin Z 500 mg under fasted conditions
Period 2:
* Day 1: Nikkomycin Z 500 mg with high fat breakfast Receives: Drug: Nikkomycin Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of Nikkomycin Z absorption under fed and fasting conditions
Measured: 24 hours
Secondary outcomes (1)
Extent of Nikkomycin Z urinary excretion
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionJun 2013
Why it stopped: Insufficient # subjects available for 2nd group; evaluating alternate study site
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 University of ArizonaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn R Matthias, PharmD, Principal investigator, University of ArizonaDavid E Nix, PharmD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647256
- Sponsor's protocol ID
- VFCE-2011-004
- Status last verified
- Sep 2013
- First submitted
- 16 Jul 2012
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nikkomycin Z Bioavailability After Single Dose Administration Under Fed (High Fat Meal) Compared to Fasting Conditions
- ClinicalTrials.gov ID
- NCT01647256
- Acronym / sponsor ID
- VFCE-2011-004
- Conditions
- Healthy
- Keywords
- Bioavailability, Fed, Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient # subjects available for 2nd group; evaluating alternate study site
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jul 2012 (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 primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.
Detailed description
To compare the single-dose bioavailability of Nikkomycin Z 500 mg (two 250 mg capsules) under fed and fasting conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nikkomycin Z fed - fasting | Experimental | Drug: Nikkomycin ZPeriod 1: * Day 1: Nikkomycin Z 500 mg with high fat breakfast Period 2: * Day 1: Nikkomycin Z 500 mg under fasted conditions |
| Nikkomycin Z fasting - fed | Experimental | Drug: Nikkomycin ZPeriod 1: * Day 1: Nikkomycin Z 500 mg under fasted conditions Period 2: * Day 1: Nikkomycin Z 500 mg with high fat breakfast |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be at least 18 years of age and not over 40 years of age
- Be male, or female (non childbearing potential or using adequate contraception)
- Have a body mass index between 18 and 29 kg/m2
- Able to understand the study and give written informed consent
- Be determined healthy based on a medical and laboratory evaluation
Key exclusion criteria (18 listed)
- Patients under the age of 18 years or over 40 years of age
- Current smoker or history of smoking within 3 months of participation
- Inability to comprehend study and provide written informed consent
- Inability to comply with the study requirements
- History of or current evidence of major organ disease
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 |
|---|---|---|
| Nikkomycin ZCapsule, 500 mg, single-dose | Drug | Nikkomycin Z fasting - fed, Nikkomycin Z fed - fasting |
Primary outcome
Rate and extent of Nikkomycin Z absorption under fed and fasting conditions
Time frame: 24 hours
1 secondary outcome
Extent of Nikkomycin Z urinary excretion
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Insufficient # subjects available for 2nd group; evaluating alternate study site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Kathryn R Matthias, PharmD principal investigator
University of Arizona
David E Nix, PharmD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nikkomycin Z in people with Healthy, run by University of Arizona at 1 site in United States.
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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Insufficient # subjects available for 2nd group; evaluating alternate study site). Results are not available in the source record.
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?
Rate and extent of Nikkomycin Z absorption under fed and fasting conditions (time frame: 24 hours). 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 17 Sep 2013.