HealthyTracer PilotNCT04535934
Novel Approaches for Quantitative Assessment of Adherence
An observational study of Healthy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Approximately 12 adults subjects will be enrolled. Participants will be randomized to one of two directly observed dosing regimens with 2mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week OR 3 doses/week followed by 7 doses/week. 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?
- Adenine 5+ (five stable-labeled nitrogens)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 15 Nov 2022
- Phase
- Observational
- 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
Study population: Healthy adult participants with no contraindicated medical conditions or medications.
Who may be able to join
- Ambulatory 18-40 year old adults.
- Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.
Who cannot join
- Inability to give informed consent
- Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
- Current breastfeeding
- Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
- GFR estimate < 60 ml/min (MDRD equation).
- Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
Show all 11Show fewer
- Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
- Symptomatic hemoglobinopathies or active hemolysis.
- Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.
- Any investigational agents within 30 days of enrollment.
- Plan to donate blood or plasma during study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Approximately 12 adults subjects will be enrolled. Participants will be randomized to one of two directly observed dosing regimens with 2mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week OR 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by a 12-week washout period for a total study duration of approximately 36 weeks.
Dried blood spots (DBS) and whole blood will be collect weekly. Urine will be collected less frequently, about every 2 weeks. The ratio of ATP 5+ to naturally occurring ATP 2+ is dried blood spots will be the primary outcome, as adenine is phosphorylated to ATP in red blood cells. Breakdown products will be measured in urine.
Investigators will allow flexibility in terms of which days are used for dosing for the 1, 3, and 4 dose(s)/week regimens. This is scientifically justified as investigators expect a 20-30 day half-life of ATP 5+ in DBS.
Read the detailed description
Approximately twelve healthy adult volunteers with no contraindicated medical conditions or medications will be recruited from CU/Denver and the surrounding community.
Participants will be randomized to one of 2 sequences consisting of two directly observed dosing regimens with 2mg adenine 5+ per dose, 1 dose/week followed by 4 doses/week or 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by an approximately 12-week washout period for a total study duration of approximately 36 weeks. The rationale for this study design is several fold. First, the lower doses are given initially to minimize the potential effects of carry-over in the second regimen. Second, 1 to 7 doses/week encompass a wide range of simulated adherence rates to assess the promise of this taggant, adenine 5+, as an adherence biomarker. Third, the 12 week duration is designed to achieve ~90% of steady-state given an estimated half-life of 20-30 days.
- Conditions
- Healthy
- Being tested
- Adenine 5+ (five stable-labeled nitrogens)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenine 5+ (five stable-labeled nitrogens)Other
Also called taggant
taggant coencapsulated with an excipient
| Study group | Role | What they receive |
|---|---|---|
| 1 dose/week followed by 4 doses/week | Directly observed dosing regimen with 2 mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week. The duration of each dosing regimen will be approximately 12 weeks. A washout period of approximately 12 weeks will separates the dosing regimens. Receives: Other: Adenine 5+ (five stable-labeled nitrogens) | |
| 3 doses/week followed by 7 doses/week. | Directly observed dosing regimen with 2 mg adenine 5+ (five stable-labeled nitrogens) as follows: 3 doses/week followed by 7 doses/week. The duration of each dosing regimen will be approximately 12 weeks. A washout period of approximately 12 weeks will separates the dosing regimens. Receives: Other: Adenine 5+ (five stable-labeled nitrogens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of ATP 5+ to ATP 2+ in DBS
Ratio of ATP 5+ to ATP 2+ in DBS following directly observed therapy with 2mg of adenine 5+ at 1, 3, 4, and 7 doses/week
Measured: 9 months
Dose-proportionality ATP 5+ to ATP 2+ in DBS
Dose-proportionality to relate ATP 5+ to ATP 2+ in DBS with adherence rate.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start31 Aug 2020
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
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 Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Anderson, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535934
- Sponsor's protocol ID
- 20-0332
- Other IDs
- R01AI122298
- Acronym
- Tracer Pilot
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2020
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches for Quantitative Assessment of Adherence
- ClinicalTrials.gov ID
- NCT04535934
- Acronym / sponsor ID
- Tracer Pilot / 20-0332
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Sep 2020 (actual)
- 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.
Approximately 12 adults subjects will be enrolled. Participants will be randomized to one of two directly observed dosing regimens with 2mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week OR 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by a 12-week washout period for a total study duration of approximately 36 weeks.
Dried blood spots (DBS) and whole blood will be collect weekly. Urine will be collected less frequently, about every 2 weeks. The ratio of ATP 5+ to naturally occurring ATP 2+ is dried blood spots will be the primary outcome, as adenine is phosphorylated to ATP in red blood cells. Breakdown products will be measured in urine.
Investigators will allow flexibility in terms of which days are used for dosing for the 1, 3, and 4 dose(s)/week regimens. This is scientifically justified as investigators expect a 20-30 day half-life of ATP 5+ in DBS.
Detailed description
Approximately twelve healthy adult volunteers with no contraindicated medical conditions or medications will be recruited from CU/Denver and the surrounding community.
Participants will be randomized to one of 2 sequences consisting of two directly observed dosing regimens with 2mg adenine 5+ per dose, 1 dose/week followed by 4 doses/week or 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by an approximately 12-week washout period for a total study duration of approximately 36 weeks. The rationale for this study design is several fold. First, the lower doses are given initially to minimize the potential effects of carry-over in the second regimen. Second, 1 to 7 doses/week encompass a wide range of simulated adherence rates to assess the promise of this taggant, adenine 5+, as an adherence biomarker. Third, the 12 week duration is designed to achieve ~90% of steady-state given an estimated half-life of 20-30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 dose/week followed by 4 doses/week | – | Other: Adenine 5+ (five stable-labeled nitrogens)Directly observed dosing regimen with 2 mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week. The duration of each dosing regimen will be approximately 12 weeks. A washout period of approximately 12 weeks will separates the dosing regimens. |
| 3 doses/week followed by 7 doses/week. | – | Other: Adenine 5+ (five stable-labeled nitrogens)Directly observed dosing regimen with 2 mg adenine 5+ (five stable-labeled nitrogens) as follows: 3 doses/week followed by 7 doses/week. The duration of each dosing regimen will be approximately 12 weeks. A washout period of approximately 12 weeks will separates the dosing regimens. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult participants with no contraindicated medical conditions or medications.
Key inclusion criteria (2 listed)
- Ambulatory 18-40 year old adults.
- Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.
Key exclusion criteria (11 listed)
- Inability to give informed consent
- Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
- Current breastfeeding
- Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
- GFR estimate < 60 ml/min (MDRD equation).
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 |
|---|---|---|
| Adenine 5+ (five stable-labeled nitrogens)Also: tagganttaggant coencapsulated with an excipient | Other | 1 dose/week followed by 4 doses/week, 3 doses/week followed by 7 doses/week. |
Primary outcome
Ratio of ATP 5+ to ATP 2+ in DBS
Time frame: 9 months
Ratio of ATP 5+ to ATP 2+ in DBS following directly observed therapy with 2mg of adenine 5+ at 1, 3, 4, and 7 doses/week
Dose-proportionality ATP 5+ to ATP 2+ in DBS
Time frame: 9 months
Dose-proportionality to relate ATP 5+ to ATP 2+ in DBS with adherence rate.
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 10 Mar 2025.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
Peter Anderson, PharmD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Colorado, Denver 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 2 inclusion and 11 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 10 Mar 2025. 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.
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?
Ratio of ATP 5+ to ATP 2+ in DBS (time frame: 9 months). The study lists 2 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 10 Mar 2025.