Clinical trials: BALANCE
Solid Tumours
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers
- Trial name
- NCT01931761
- Testing
- [C14] selumetinib (oral)
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib
This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to…
- Trial name
- NCT03627520
- Testing
- [14C]Sulfatinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate, Healthy Subjects
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single…
- Trial name
- NCT02059590
- Testing
- Pyridinylmethyl-14C-labeled isavuconazonium sulfate
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Venous Insufficiency, Venous Reflux
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Trial name
- NCT01549860
- Testing
- MIST Therapy
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Celleration, Inc.
Fed
Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01618825
- Testing
- Lamotrigine Tablets 25 mg, Lamotrigine
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Community-acquired Infection
GSK2251052 Mass Balance in Healthy Adult Subjects
Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions.
- Trial name
- NCT01475695
- Testing
- 14C GSK2251052
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Adult Male
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects.
- Trial name
- NCT04415645
- Testing
- [14C]-VVZ-149
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Vivozon, Inc.
Healthy Subjects
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults.
- Trial name
- NCT02919319
- Testing
- ACT-541468 (Formulation A), ACT-541468 (Formulation B), 14C-labeled ACT-541468
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Solid Tumor
A Phase 1 TH-302 Mass Balance Trial
This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer…
- Trial name
- NCT02076230
- Testing
- [14C] TH-302 (Label 1), [14C] TH-302 (Label 2), Unlabeled TH-302
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Renal Hemodynamics
Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide
This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when…
- Trial name
- NCT00909519
- Testing
- naproxcinod, Naproxen, furosemide
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- NicOx
Non Small Cell Lung Cancer
TGRX-326 Pharmacokinetic Mass Balance
This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.
- Trial name
- NCT06438367
- Testing
- [14C]TGRX-326
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shenzhen TargetRx Co., Ltd.
HIV Infections
A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation
This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.
- Trial name
- NCT05776108
- Testing
- Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1), Cabotegravir DT Formulation (test 2)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Male Adults
To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects
To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects
- Trial name
- NCT07036458
- Testing
- 14C Epaminurad Oral Solution
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical
Healthy
Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.
- Trial name
- NCT04704739
- Testing
- GLPG1205 film-coated tablets, [14C]-GLPG1205 solution for infusion, GLPG1205 capsules
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants
Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body.
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
- Trial name
- NCT06221475
- Testing
- BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion, [14C]-BAY2927088 oral solution
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bayer
Inflammatory Bowel Diseases, Short Bowel Syndrome
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches.
- Conditions
- Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
- Trial name
- NCT03451253
- Testing
- amino acid mixture beverage, glucose-based sports drink
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Entrinsic Bioscience Inc.
Healthy Participants
A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004
This study in healthy volunteers aims to answer these questions: Does the test medicine cause any important side effects? What are the blood levels of the test medicine and how quickly does the body get rid of it? How much of the…
- Trial name
- NCT06857695
- Testing
- AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion, [14C]AZD5004 Oral Solution
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Fasting
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503437
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream.
- Trial name
- NCT01448395
- Testing
- [14C]NXL104
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer