Clinical trials: Drug Dose
Multiple Myeloma
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed…
- Trial name
- NCT04075721
- Testing
- M3258, M3258 20 mg
- Where
- 7 sites in United States, France
- Volunteers
- 10 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
- Trial name
- NCT02706834
- Testing
- TAK-828
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Virus, Zika, Zika Virus Disease
Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart.
- Conditions
- Virus, Zika, Zika Virus Disease, Flavivirus Infections, Healthy Participants
- Trial name
- NCT03343626
- Testing
- PIZV
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Takeda
Acute Renal Failure
Low Dose Thymoglobin in Renal Transplant Patients
This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients.
- Trial name
- NCT01280617
- Testing
- Thymoglobulin, Thymoglobulin 0.75mg/kg dose
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Lahey Clinic
Friedreich Ataxia
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity.
- Trial name
- NCT03214588
- Testing
- TAK-831
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neurocrine Biosciences
Advanced Non-hematologic Malignancies
A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies
This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB…
- Trial name
- NCT00830869
- Testing
- IXAZOMIB
- Where
- 7 sites in United States, Canada
- Volunteers
- 116 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone
Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics…
- Trial name
- NCT00785213
- Testing
- Rosiglitazone 4 mg Tablets, Quinine Sulfate 324 mg Capsules
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Obstructive Sleep Apnea
Crossover Trial of AD109 in Obstructive Sleep Apnea
This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.
- Trial name
- NCT04580394
- Testing
- AD109, Atomoxetine, R-oxybutynin
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Apnimed
Ischemic Heart Disease
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery…
- Trial name
- Engensis (NCT01422772)
- Testing
- VM202-0.5 mg, VM202-1.0 mg, VM202-2.0 mg
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Helixmith Co., Ltd.
Pulmonary Disease, Chronic Obstructive
The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus
The primary objective of the trial is to show superiority in lung function of once daily (2 inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to twice daily (one inhalation) treatment with…
- Trial name
- NCT03240575
- Testing
- Tiotropium, Olodaterol, Fluticasone propionate
- Where
- 45 sites in United States
- Volunteers
- 302 people
- Sponsor
- Boehringer Ingelheim
Obesity
A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range
Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide.
- Trial name
- NCT05671653
- Testing
- PF-07081532, Semaglutide
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Type 2 Diabetes Mellitus
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
- Trial name
- NCT00511472
- Testing
- MK-0941, LANTUS insulin
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Carcinoid Syndrome
Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of…
- Trial name
- CAMPANULA (NCT01018953)
- Testing
- BIM 23A760
- Where
- 54 sites in Austria, Belgium and 16 more
- Volunteers
- 8 people
- Sponsor
- Ipsen
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829712
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Major Depressive Disorder
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin…
- Trial name
- REVIVE (NCT01488071)
- Testing
- Vortioxetine (Lu AA21004), Agomelatine
- Volunteers
- 495 people
- Sponsor
- H. Lundbeck A/S
Healthy
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive [Ethinyl estradiol/Norethisterone (EE/NET)] in healthy female participants.
- Trial name
- NCT07215806
- Testing
- Evobruitnib, Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Schizophrenia
Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.
- Trial name
- NCT01760993
- Testing
- SPD489
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Shire
Hypertension
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood…
- Trial name
- BP CRUSH (NCT00791258)
- Testing
- amlodipine and olmesartan medoxomil tablets, hydrochlorothiazide tablets
- Where
- 72 sites in United States
- Volunteers
- 999 people
- Sponsor
- Daiichi Sankyo