Clinical trials: Microdosing
Alzheimer Disease
A Study to Investigate the Regional Brain Kinetics of Brain Drug Transporters Using P-glycoprotein and Breast Cancer Resistance Protein Substrates and by Using the Positron Emission Tomography Ligand 11C-JNJ-63779586 in the Human Brain
The purpose of this study is to investigate the total body biodistribution and radiation dosimetry of 11C-JNJ-63779586 by Positron Emission Tomography (PET) in healthy young adult males (Part A); to estimate and compare the…
- Trial name
- NCT03089918
- Testing
- 11C-JNJ-63779586
- Where
- 2 sites in Belgium
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Solid Tumour
CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
This is a multi-center, open-label Phase 0 Master Protocol in Australia designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumour microenvironment (TME) when administered intratumourally in…
- Trial name
- NCT04891718
- Testing
- MVC-101, Nivolumab, MVC-101 + Nivolumab
- Where
- 3 sites in Australia
- Sponsor
- Presage Biosciences
Obesity & Overweight, Weight Loss
GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study
This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health…
- Conditions
- Obesity & Overweight, Weight Loss, Preventative Health, Body Weight
- Trial name
- FLOURISH (NCT07588984)
- Testing
- Noom Weight, Free Tier, Education-only control
- Where
- United States
- Volunteers
- 2,310 people
- Sponsor
- Noom Inc.
Neuroendocrine Tumors
An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.
- Trial name
- NCT04440956
- Testing
- 64Cu-SARTATE
- Volunteers
- 10 people
- Sponsor
- Clarity Pharmaceuticals Ltd
Head and Neck Squamous Cell Carcinoma
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered…
- Trial name
- NCT06366451
- Testing
- Rilvegostomig, Volrustomig, Sabestomig
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Presage Biosciences
Soft Tissue Sarcoma Adult
Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
- Trial name
- NCT03056599
- Testing
- Multiple drug microinjection, CIVO device
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Presage Biosciences
MASH, PSC
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers…
- Conditions
- MASH, PSC, Fibrostenotic Crohn's Disease, Healthy Volunteers
- Trial name
- NCT06562361
- Testing
- [68Ga]Ga-DOTA-Cys-ATH001
- Where
- 3 sites in Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Antaros Medical
Breast Cancer, Healthy Volunteers
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Primary Objectives: To assess the excretion balance after oral and IV administration of [14C]-SAR439859 To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and…
- Trial name
- NCT04940026
- Testing
- amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Head and Neck Cancer
Intratumoral Microdosing of TAK-981 in Head and Neck Cancer
This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of TAK-981 and TAK-981 combined with…
- Trial name
- NCT04065555
- Testing
- TAK-981, Cetuximab, Avelumab
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- Presage Biosciences
Opioid Use Disorder, Opioid Use
Novel Induction to Buprenorphine/Naloxone
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction.
- Conditions
- Opioid Use Disorder, Opioid Use, Opioid Abuse, Opioid Misuse
- Trial name
- NCT05644587
- Testing
- buprenorphine/naloxone
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Bicycle Health
Pain, Intractable, Pain, Back
BurstDR™ micrOdosing stimuLation in De-novo Patients
The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
- Trial name
- BOLD (NCT03350256)
- Testing
- Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Head and Neck Squamous Cell Carcinoma
PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC
This is a multi-center, open-label Phase 0 substudy designed to study the localized pharmacodynamics (PD) of TAK-676 alone or in combination with Carboplatin, 5-FU, or Paclitaxel within the tumor microenvironment (TME) when…
- Trial name
- NCT06062602
- Testing
- TAK-676, Carboplatin, 5-FU
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Presage Biosciences
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma
PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation…
- Trial name
- NCT06413095
- Testing
- Pembrolizumab, MK-0482 + Pembrolizumab, MK-4830 + Pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 13 people
- Sponsor
- Presage Biosciences
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06273852
- Testing
- PBA-0405
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pure Biologics S.A.
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0111 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06700070
- Testing
- PBA-0111
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Pure Biologics S.A.
Lymphoma
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
Many cancer patients are prescribed drugs to which their cancer is already resistant - and thus suffer toxicity with no potential for benefit. Previous attempts to assess chemoresistance or sensitivity in vitro have failed.
- Trial name
- NCT01831505
- Testing
- Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Presage Biosciences
Solid Tumor
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose…
- Trial name
- NCT04541108
- Testing
- Rilvegostomig, Volrustomig, Sabestomig
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Presage Biosciences
Longevity, Quality of Life
Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures
The goal of this clinical study has two objectives. The Primary Objective is to evaluate the effectiveness of microdosed GLP-1 receptor agonists in improving measures of health, quality of life, and longevity.
- Conditions
- Longevity, Quality of Life, Mood, Inflammation
- Trial name
- NCT07092605
- Testing
- GLP-1
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- AgelessRx
HNSCC
Intratumoral Microdosing of Motolimod in HNSCC
This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with…
- Trial name
- NCT04272333
- Testing
- Motolimod, Nivolumab, Motolimod + Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Presage Biosciences
Healthy
Early Phase I Microdosing Study of ORM-14540 and ORM-12741
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.
- Trial name
- NCT00831077
- Testing
- ORM-14540, ORM-12741
- Where
- Finland
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma