Clinical trials: Tolerability
Depression
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
- Trial name
- NCT00610649
- Testing
- MK-8777
- Volunteers
- 54 people
- Sponsor
- Merck Sharp & Dohme LLC
Mixed Dyslipidemia, Hypercholesterolaemia
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk.
- Trial name
- MEDICI (NCT07614958)
- Where
- United Kingdom
- Volunteers
- 426 people
- Sponsor
- A. Menarini International Licensing S.A.
Tourette Syndrome
A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome
This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome.
- Trial name
- NCT03651726
- Testing
- THX-110 (dronabinol plus PEA)
- Where
- 2 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Neurothera Labs Inc.
Solid Tumors
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.
- Trial name
- KEYNOTE-603 (NCT03313778)
- Testing
- mRNA-4157, Pembrolizumab, SoC Treatment
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 161 people
- Sponsor
- ModernaTX, Inc.
Ocular Inflammation and Pain After Cataract Surgery
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo.
- Trial name
- NCT04089735
- Testing
- APP13007, 0.05%, APP13007, 0.1%
- Where
- 9 sites in United States
- Volunteers
- 165 people
- Sponsor
- Formosa Pharmaceuticals, Inc.
Solid Tumor, Adult, NSCLC
Study to Evaluate D-1553 in Subjects With Solid Tumors
This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with…
- Conditions
- Solid Tumor, Adult, NSCLC, CRC
- Trial name
- NCT04585035
- Testing
- D-1553, D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other
- Where
- 25 sites in United States, Australia and 2 more
- Volunteers
- 180 people
- Sponsor
- InventisBio Co., Ltd
Moderate to Severe Plaque-type Psoriasis
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
- Trial name
- FEATURE (NCT01555125)
- Testing
- secukinumab 150 mg, secukinumab 300 mg
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
Drug Safety, Respiratory Syncytial Virus Infections
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated.
- Trial name
- NCT01355016
- Testing
- MDT-637
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- MicroDose Therapeutx, Inc
Bipolar Disorder
Bipolar Study in Adults at Least 18 Years of Age
Bipolar study of tolerability, clinical response and patient satisfaction
- Trial name
- NCT00067938
- Testing
- lamotrigine
- Where
- 308 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- GlaxoSmithKline
Metastatic Melanoma, Malignant Metastatic Melanoma
A Safety and MORAb-028 Dose Determination Study in Subjects With Metastatic Melanoma
The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective, and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.
- Conditions
- Metastatic Melanoma, Malignant Metastatic Melanoma, Advanced Melanoma, Melanoma
- Trial name
- NCT01212276
- Testing
- MORAb-028
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Morphotek
Diabetes Mellitus, Type 2
A Clinical Study to Assess the Safety, Tolerability, and Activity of Oral SRT2104 Capsules Administered for 28 Days to Subjects With Type 2 Diabetes Mellitus
Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and safety clinical study of SRT2104 administered orally once daily for 28 consecutive days.
- Trial name
- NCT01018017
- Testing
- SRT2104
- Where
- Germany
- Volunteers
- 86 people
- Sponsor
- GlaxoSmithKline
Parkinson Disease, Cognitive Dysfunction
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive…
- Trial name
- NCT04476017
- Testing
- SAGE-718
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Peripheral Arterial Disease
Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease
The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione.
- Trial name
- CLAUDIA (NCT06774040)
- Testing
- Etribnabdione 25 mg BID, Etribnabdione 50 mg BID
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- VivaCell Biotechnology España
Peritoneal Carcinomatosis, Ovarian Cancer
Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis
RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq.
- Trial name
- NCT03732768
- Testing
- Radspherin
- Where
- 4 sites in Belgium, Norway and 1 more
- Volunteers
- 21 people
- Sponsor
- Oncoinvent Solutions AS
Cocaine Use Disorder
A Study to Investigate the Interaction Between TMP-301 and Cocaine.
This will be a randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral TMP-301, given concurrently with cocaine.
- Trial name
- NCT06648668
- Testing
- TMP-301
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Tempero Bio, Inc.
Renal Cell Carcinoma Metastatic
A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.
- Trial name
- NCT06321250
- Testing
- JMKX003948
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Jemincare
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults
The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.
- Trial name
- NCT06821750
- Testing
- PF-07314470
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Glaucoma, Ocular Hypertension
A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension
The purpose of the study is to examine how preservative free tafluprost ophthalmic solution (0.0015%) is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure.
- Trial name
- NCT02102750
- Testing
- Preservative free tafluprost opthalmic solution
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 17 people
- Sponsor
- Santen Oy
Contraception
Evaluation of the Efficacy and Safety of LevoCept
To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study
- Trial name
- NCT02882191
- Testing
- LevoCept
- Where
- 16 sites in United States
- Volunteers
- 279 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Healthy Male and Female Subjects
Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.
- Trial name
- NCT06732804
- Testing
- AVT80, Geographical region 1 Entyvio, Geographical region 2 Entyvio
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 385 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG