Novel Approaches for Quantitative Assessment of Adherence

NCT04535934 | Completed

• 2 other identifiers: 20-0332R01AI122298
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  9 months

Study Arms (2)

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.

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.

Other: Adenine 5+ (five stable-labeled nitrogens)

Interventions

Adenine 5+ (five stable-labeled nitrogens) OTHER

taggant coencapsulated with an excipient

Also known as: taggant

1 dose/week followed by 4 doses/week; 3 doses/week followed by 7 doses/week.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult participants with no contraindicated medical conditions or medications.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for DNA will be obtained at the Visit 1 visit for those who consent to testing.

Study Officials

• Peter Anderson, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: September 2, 2020
• Study Start: August 31, 2020
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)