Clinical trials: Pharmacodynamics
Infertility
Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to…
- Trial name
- NCT01176175
- Testing
- Progesterone
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Productos Científicos S. A. de C. V.
Diabetes Mellitus, Type 2
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as…
- Trial name
- NCT01515657
- Testing
- PL2200 Aspirin Capsules, Immediate-Release Aspirin Tablets, Enteric-coated aspirin caplets
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- PLx Pharma
Healthy
Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
- Trial name
- NCT02211157
- Testing
- BIBR 796 BS, high fat breakfast
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Neoplasms, Medication Toxicity
Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers
This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.
- Conditions
- Neoplasms, Medication Toxicity, Tolerance
- Trial name
- NCT03077477
- Testing
- AMXT 1501
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aminex Therapeutics, Inc.
Primary Ciliary Dyskinesia (PCD)
Study of Inhaled RCT1100 in Adults With PCD Caused by Pathogenic Mutations in the DNAI1 Gene to Measure Mucociliary Clearance
This is a multi-dose study with RCT1100 and is designed to provide safety, tolerability and preliminary efficacy data for future clinical studies.
- Trial name
- NCT06633757
- Testing
- RCT1100
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 14 people
- Sponsor
- ReCode Therapeutics
Advanced Solid Tumors
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.
- Trial name
- NCT05740202
- Testing
- SHR-7367
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Rare Diseases
A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.
- Trial name
- NCT04765553
- Testing
- NI-0501, Saline
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Dyslipidemia
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia
This is a Phase I study to assess the safety, tolerability and pharmacokinetics (PK), and pharmacodynamics (PD) of AZD8233, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD8233 in subjects with…
- Trial name
- NCT04155645
- Testing
- AZD8233 subcutaneous injection
- Where
- 7 sites in United States
- Volunteers
- 34 people
- Sponsor
- AstraZeneca
Healthy
Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise®…
- Trial name
- NCT03179345
- Testing
- Gabapentin, Pregabalin
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Depomed
Plaque Psoriasis
A Trial to Understand How Safe and Well Tolerated ZP9830 is and How it Works in People With Plaque Psoriasis Over an 8-week Treatment Period
The purpose of this trial is to investigate the effects of repeated administration of ZP9830 for 8 weeks in participants with plaque psoriasis.
- Trial name
- NCT07733089
- Testing
- ZP9830
- Where
- Netherlands
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
Chronic Myeloid Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia
The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.
- Trial name
- NCT00464113
- Testing
- XL228
- Where
- 6 sites in United States
- Volunteers
- 49 people
- Sponsor
- Exelixis
Hepatitis C
Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive…
- Trial name
- NCT01329913
- Testing
- MK-6325
- Volunteers
- 36 people
- Sponsor
- Merck Sharp & Dohme LLC
Granulin Mutation
Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation
The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.
- Trial name
- NCT02149160
- Testing
- FRM-0334
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- FORUM Pharmaceuticals Inc
Type 1 Diabetes
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
- Trial name
- NCT00519623
- Testing
- PassPort(R) Transdermal Insulin Delivery System
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Altea Therapeutics
IBD
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD Effects in Male Volunteers
This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.
- Trial name
- NCT02914262
- Testing
- AKB-4924
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Aerpio Therapeutics
Healthy
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of…
- Trial name
- NCT03487562
- Testing
- DWP14012 Amg, DWP14012 Bmg, Clarithromycin
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination…
- Conditions
- Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Trial name
- KAT6 (NCT04606446)
- Testing
- PF-07248144, Fulvestrant, Letrozole
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 320 people
- Sponsor
- Pfizer
T2DM (Type 2 Diabetes Mellitus)
Single Escalating Dose Study Of HSK7653 In Healthy Subjects
To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects
- Trial name
- NCT05983289
- Testing
- HSK7653
- Where
- China
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy Volunteers, Pharmacodynamics of Mirabegron
A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.
To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron.
- Trial name
- NCT01284868
- Testing
- mirabegron, Bisoprolol, propranolol
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Acute Low Back Pain
A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain.
- Trial name
- NCT00952068
- Testing
- Tramadol Contramid® OAD 200mg
- Volunteers
- 47 people
- Sponsor
- Labopharm Inc.
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