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NCT04535934: Tracer Pilot
Novel Approaches for Quantitative Assessment of Adherence
trial testing Adenine 5+ (five stable-labeled nitrogens) in Healthy in 15 participants. Completed in 15 November 2022.
15 November 2022
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 15 |
| Start date | 31 August 2020 |
| Primary completion | 15 November 2022 |
| Estimated completion | 15 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Adenine 5+ (five stable-labeled nitrogens)
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 40, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04535934
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04535934 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 10 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04535934.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing