Find research datasets worth reusing

Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

ClinicalTrials.gov study NCT02004691. IPD Sharing: YES. Countries: 17. Publications: 1.

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212

ClinicalTrials.gov study NCT01072175. IPD Sharing: UNDECIDED. Countries: 2. Publications: 9.

Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

ClinicalTrials.gov study NCT03264989. IPD Sharing: YES. Countries: 1. Publications: 3.

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Fai

ClinicalTrials.gov study NCT02678312. IPD Sharing: YES. Countries: 29. Publications: 2.

Study of Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of LNP023 in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

ClinicalTrials.gov study NCT03439839. IPD Sharing: YES. Countries: 3. Publications: 1.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults

ClinicalTrials.gov study NCT03522506. IPD Sharing: YES. Countries: 1. Publications: 1.

A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)

ClinicalTrials.gov study NCT03268941. IPD Sharing: YES. Countries: 1. Publications: 1.

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabraf

ClinicalTrials.gov study NCT02124772. IPD Sharing: YES. Countries: 5. Publications: 3.

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of Venglustat in Late-onset GM2

ClinicalTrials.gov study NCT04221451. IPD Sharing: YES. Countries: 13. Publications: 1.

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

ClinicalTrials.gov study NCT03896152. IPD Sharing: YES. Countries: 4. Publications: 1.

opencc-zeroMay 2020View details →

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Data from: Validation of serum neurofilaments as prognostic & potential pharmacodynamic biomarkers for ALS

Objective. Identify preferred neurofilament assays, and clinically validate serum NfL and pNfH as prognostic and potential pharmacodynamic biomarkers relevant to ALS therapy development. Methods. Prospective, multi-center, longitudinal observational study of patients with ALS (n=229), primary lateral sclerosis (PLS, n=20) and progressive muscular atrophy (PMA, n=11). Biological specimens were collected, processed and stored according to strict standard operating procedures (SOPs) 1. Neurofilament assays were performed in a blinded manner by independent contract research organizations (CROs). Results. For serum NfL and pNfH measured using the Simoa assay, there were no missing data (i.e. both technical replicates below the lower limit of detection were not encountered). For the Iron Horse and Euroimmun pNfH assays, such missingness was encountered in ~4% and ~10% of serum samples respectively. Mean coefficients of variation (CVs) for pNfH in serum and CSF were ~4-5% and ~2-3% respectively in all assays. Baseline NfL concentration, but not pNfH, predicted the future ALSFRS-R slope and survival. Incorporation of baseline serum NfL into mixed effects models of ALSFRS-R slopes yields an estimated sample size saving of ~8%. Depending on the method used to estimate effect size, use of serum NfL (and perhaps pNfH) as pharmacodynamic biomarkers, instead of the ALSFRS-R slope, yields significantly larger sample size savings. Conclusions. Serum NfL may be considered a clinically validated prognostic biomarker for ALS. Serum NfL (and perhaps pNfH), quantified using the Simoa assay, have potential utility as pharmacodynamic biomarkers of treatment effect.

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Pharmacodynamics parameters underlying the manuscript: The effect of morning versus evening administration of empagliflozin on its pharmacokinetics and pharmacodynamics characteristics in healthy adults: a two-way crossover, non-randomised trial

Background: Empagliflozin is an SGLT2 inhibitor approved for use in patients with Diabetes Mellitus type 2 (DMT2) with- or without other cardiovascular disease. Empagliflozin is taken once daily without rationale on the optimal timing for administration. This study aimed to determine the chronopharmacological effects of morning vs evening administration of empagliflozin 10 mg in Healthy Egyptian adults, by investigating the pharmacokinetics and pharmacodynamics parameters of empagliflozin depending on the intake time. Methods: An open label, sequential, two‐way crossover trial comprised two periods with a washout period of 7 days. Pharmacokinetics parameters (tmax (h), Cmax (ng/ml), AUC 0-t (ng.h/ml)) as primary endpoints, and (AUC 0 to ∞(ng.h/ml)) as secondary endpoint were assessed. Method validation was done prior to injection in LC/MS/MS and samples were processed by Liquid-Liquid extraction. The pharmacodynamic profile (UGE 0-24) was determined after method validation (glucose hexokinase method). Results: Tmax increased by (35%) in the evening phase compared to the morning phase, while Cmax decreased by (-6.5%)in the evening dose compared to the morning dose. Besides, AUC0 to ∞ increased in the evening phase by (8.25%) compared to the morning phase. The mean cumulative amount of glucose excreted; UGE (0-24) increased by (43%) in the evening dose compared to the morning dose Conclusion: Despite there was a significant difference between morning and evening doses, it didn't reach the significant level, thus, it can be concluded that there is no difference between the morning and evening doses.

opencc-zeroFeb 2021View details →

Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes

ClinicalTrials.gov study NCT01276288. IPD Sharing: Not stated. Countries: 1. Publications: 3.

Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies

ClinicalTrials.gov study NCT01781429. IPD Sharing: Not stated. Countries: 1. Publications: 3.

Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

ClinicalTrials.gov study NCT03318523. IPD Sharing: YES. Countries: 9. Publications: 3.

A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants.

ClinicalTrials.gov study NCT00942175. IPD Sharing: Not stated. Countries: 1. Publications: 2.

Propofol Pharmacokinetics and Pharmacodynamics Modelling

ClinicalTrials.gov study NCT02713698. IPD Sharing: Not stated. Countries: 1. Publications: 1.

closedIPD-NOFeb 2026View details →

Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)

ClinicalTrials.gov study NCT04059406. IPD Sharing: NO. Countries: 5. Publications: 0.

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis

ClinicalTrials.gov study NCT02195349. IPD Sharing: YES. Countries: 2. Publications: 1.

Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1

ClinicalTrials.gov study NCT01009814. IPD Sharing: Not stated. Countries: 1. Publications: 3.