None listed
Conditions
Brief summary
This is a proof-of-concept study and is not formally powered for hypothesis testing. This is an exploratory, proof-of-concept, open-label study conducted in three independent cohorts (creatine/creatinine, phenylalanine, and tryptophan). Participants will be assigned to a cohort at screening. Participants may be enrolled into any cohort in a non-sequential manner; enrolment is not restricted to a predefined order. This flexible approach allows for parallel recruitment across cohorts based on eligibility and operational readiness. The cohorts consist of: • Cohort 1 = Administration of Creatine for monitoring of Creatinine • Cohort 2= Administration and monitoring of Phenylalanine • Cohort 3 = Administration and monitoring of Tryptophan The primary objective is to evaluate the ability of TDM monitoring patches to detect and continuously track target analytes in interstitial fluid (ISF). Secondary objectives are to assess the relationship between patch-derived signal and blood analyte concentrations and to evaluate device-to-device reproducibility across multiple patches Approximately 12 participants per cohort will be enrolled, with a total sample size of approximately 36 participants across the three cohorts. The sample size is considered sufficient to assess feasibility, signal detection, and variability.
Interventions
This is an exploratory, proof-of-concept, open-label study conducted in three independent cohorts (creatine/creatinine, phenylalanine, and tryptophan). This study will explore the Nutromics Sensor Device to measure the multiple different analytes in different cohorts. These patches will be applied on participant's upper arms. These patches contain microneedles that are inserted through the skin into the interstitial fluid layer that will measure the analytes mentioned above.
participants will r
This is an exploratory, proof-of-concept, open-label study conducted in three independent cohorts (creatine/creatinine, phenylalanine, and tryptophan). This study will explore the Nutromics Sensor Device to measure the multiple different analytes in different cohorts. These patches will be applied on participant's upper arms. These patches contain microneedles that are inserted through the skin into the interstitial fluid layer that will measure the analytes mentioned above. participants will receive a single oral bolus of the assigned supplement relative to the analyte tested (cohort-specific): • Cohort 1: Oral bolus 10.0 grams Creatine ethyl ester • Cohort 2: Oral bolus 5.0 grams Phenylalanine • Cohort 3: Oral bolus 100mg/kg up to 6g Tryptophan All supplements come in the form of a powder, that is created as a solution with water. All participants will be required to consume the supplement solution with oversight of the clinical study team to ensure that the oral dose has been completely administered. Allocation is non-randomised. Participants are assigned to one of three cohorts based on (a) cohort-specific eligibility criteria and (b) participant availability relative to the cohort visit schedule. Interim data reviews after the first 7-10 participants may be split up equally across the 3 different cohorts, followed by the next 7-10 participants also equally split across 3 cohorts. Participants will attend a screening visit at the clinic site for informed consent and eligibility assessments. On the treatment day, participants will arrive to the clinic site for scheduled procedures where monitoring patches will be applied to begin, followed by a 2-hour burn-in period (2-hour wait period). Baseline blood samples will then be collected prior to oral administration of the assigned analyte (cohort-dependent: creatine, phenylalanine or tryptophan). Serial blood samples will be collected over a 12-hour period post-dose to capture analyte kinetics. These blood samples will then be collected at predefined timepoints such as pre-dose (endogenous measurement) and at 1 hour (±15 min), 2 hours (±15 min), 4 hours (±15 min), 5.5 hours (±15 min), 7 hours (±30 min), 9 hours (±30 min) and 24 hours(±1 hour) post dose. Participants will then continue patch wear at home overnight. At approximately 24 hours post-application, participants will return for final blood collection (safety blood sample and blood sample of target analyte) and patch removal.
Sponsors
Nutromics Operations Pty Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18–60 years. 2. Healthy individuals without any disease, syndrome, or significant acute or chronic medical illness, as determined by the Study Investigators. 3. No clinically significant abnormalities in vital signs, serum biochemistry, haematology, or other screening assessments that would contraindicate participation. Any known disorders that impact the metabolism of the oral consumption of each supplement such as: - For creatine - participants with known kidney issues. - For phenylalanine - metabolic or neurological conditions such as 'Phenylketonuria'. - For Tryptophan - any disorders that affect serotonin production and participants that are taking any medications such as anti-depressants or migraine medications. 4. Normal renal function, as determined by the Study Investigators, including estimated creatinine clearance or eGFR within the protocol-defined acceptable range. 5. No known liver disease. 6. No known metabolic disease or disorder that may affect creatine, phenylalanine, tryptophan, or related biomarker levels. 7. Female participants of childbearing potential must have a negative pregnancy test at Screening and prior to dosing on the treatment day. 8. Participants must be willing and able to comply with study procedures, including patch application, serial blood sampling, oral analyte administration, overnight patch wear, and return for the 24-hour visit.
Exclusion criteria
1. Pregnancy, planned pregnancy during the study period, or breastfeeding. 2. Known history of renal impairment, liver disease, or metabolic disease. 3. History of migraine or recurrent migraine-type headaches. 4. Current or past co-morbid mental health condition that, in the opinion of the Study Investigators, may increase participant risk or interfere with study participation or interpretation of results. 5. Use of concomitant medications or supplements known to increase the risk of serotonin syndrome or affect serotonin pathways, including but not limited to: a) SSRIs (Selective Serotonin Reuptake Inhibitors) b) SNRIs (Serotonin Norephedrine Reuptake Inhibitors) c) MAOIs (Monoamine Oxidase Inhibitors) d) Triptans e) Tramadol f) St John’s Wort 6. Current or recent use of MDMA or other illicit drugs that, in the opinion of the Study Investigators, may increase participant risk or interfere with study outcomes. 7. Use of medications or supplements that may affect creatine, phenylalanine, tryptophan, or related analyte levels, unless deemed acceptable by the Study Investigators. 8. History of allergic reactions to adhesives, metals, plastics, or device components. 9. Skin conditions, scars, tattoos, markings, or other factors at the intended patch application site that may interfere with device placement, adhesion, or skin assessment. 10. Significant history of fainting, vasovagal reactions, or poor tolerance of blood draws. 11. Participation in another clinical trial within the last 30 days. 12. Inability to attend scheduled study visits or comply with study requirements. 13. Employee of Nutromics Operations Pty Ltd. 14. Any other condition that, in the opinion of the Principal Investigator or Study Investigators, would make participation not in the best interest of the participant or may compromise study integrity.
Outcome results
None listed