scholarly journals A phase 1 randomized study of hemodynamic effects and pharmacokinetic interactions during concomitant use of rimegepant and sumatriptan in healthy adults

2021 ◽  
Vol 4 ◽  
pp. 251581632110079
Author(s):  
Robert Croop ◽  
Andrea Ivans ◽  
Matt S Anderson ◽  
Joseph Stringfellow ◽  
Richard Bertz ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Phase 1 ◽  
Injection Site Reaction ◽  
Weighted Average ◽  
Concomitant Administration ◽  
Healthy Adults ◽  
Controlled Study ◽  
Hemodynamic Effects ◽  
Pharmacokinetic Interactions ◽  
Subcutaneous Sumatriptan

Objective: This randomized, partially-blinded, placebo-controlled study evaluated hemodynamic effects, pharmacokinetic interactions, and safety of concomitant administration of oral rimegepant and subcutaneous sumatriptan. Methods: Healthy non-smokers aged ≥18 and ≤40 years (men) or ≥18 and ≤50 years (women) were enrolled. On Day 1, subjects received 12 mg of sumatriptan as 2 subcutaneous 6 mg injections separated by 1 hour. From Days 2 to 4, subjects received rimegepant or placebo once daily (randomized 6 to 1, rimegepant to placebo). On Day 5, subjects received rimegepant or placebo, followed 2 hours later by 2 subcutaneous 6 mg injections of sumatriptan, separated by 1 hour. Sumatriptan was administered at the same times as on Day 1. Results: All 42 dosed subjects were analyzed. There were no significant differences in the time-weighted average of mean arterial pressure, diastolic blood pressure, or systolic blood pressure between treatment with rimegepant + sumatriptan and sumatriptan alone. Co-administration of rimegepant and sumatriptan had no effect on the pharmacokinetics of either drug. Overall, 93% (39/42) of subjects experienced ≥1 adverse event; injection site reaction was most common (60% [29/42]). Conclusions: Concomitant administration of oral rimegepant and subcutaneous sumatriptan to healthy adults was without hemodynamic or pharmacokinetic interaction and was safe and well tolerated.

scholarly journals A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 296
Author(s):  
Irina Kiseleva ◽  
Irina Isakova-Sivak ◽  
Marina Stukova ◽  
Marianna Erofeeva ◽  
Svetlana Donina ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Phase 1 ◽  
Healthy Adults ◽  
Controlled Study ◽  
Temperature Sensitive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Human Influenza Virus ◽  
Live Attenuated Influenza Vaccine

This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.

Electrocardiographic and Hemodynamic Effects of Panax Ginseng

2002 ◽  
Vol 36 (5) ◽  
pp. 758-763 ◽  
Author(s):  
Michael F Caron ◽  
Audrea L Hotsko ◽  
Stacy Robertson ◽  
Lilia Mandybur ◽  
Jeffrey Kluger ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Panax Ginseng ◽  
Study Drug ◽  
Healthy Adults ◽  
Controlled Study ◽  
Qtc Interval ◽  
Double Blind ◽  
Ginseng Extract ◽  
Days Of Therapy

OBJECTIVE: To determine whether Panax ginseng ingestion can acutely or chronically alter electrocardiographic parameters: PR, QRS, QT, QTc, and RR intervals, and QT and QTc interval dispersion. Effects of P. ginseng on blood pressure and heart rate also were evaluated. METHODS: This is a prospective, randomized, double-blind, placebo-controlled study of healthy adults at the University of Connecticut. Thirty subjects were randomly allocated to receive 28 days of therapy with either P. ginseng extract 200 mg or placebo. Baseline 12-lead electrocardiograms (ECGs) were obtained. Subsequent ECGs were performed following study drug ingestion at 50 minutes, 2 hours, and 5 hours on days 1 and 28. Blood pressure readings were taken with each ECG. RESULTS: P. ginseng ingestion increased the QTc interval by 0.015 seconds on day 1 at 2 hours compared with the placebo group (p = 0.03). It also reduced diastolic blood pressure from 75 ± 5 mm Hg at baseline to 70 ± 6 mm Hg at the same time point (p = 0.02). The observed effects are not believed to be clinically significant. No other statistically significant changes were found in electrocardiographic or hemodynamic variables on days 1 or 28. CONCLUSIONS: P. ginseng, at doses of 200 mg of the extract daily, increases the QTc interval and decreases diastolic blood pressure 2 hours after ingestion in healthy adults on the first day of therapy.

scholarly journals Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers

Cephalalgia ◽  
2018 ◽  
Vol 39 (1) ◽  
pp. 100-110 ◽  
Author(s):  
Jan de Hoon ◽  
Anne Van Hecken ◽  
Corinne Vandermeulen ◽  
Marissa Herbots ◽  
Yumi Kubo ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Mean Arterial Pressure ◽  
Confidence Interval ◽  
Arterial Pressure ◽  
Phase 1 ◽  
Geometric Mean ◽  
Double Blind ◽  
Parallel Group ◽  
Resting Blood Pressure ◽  
Subcutaneous Sumatriptan

Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg. Blood pressure was measured pre-dose and at prespecified times post-dose. The primary endpoint was individual time-weighted averages of mean arterial pressure, measured from 0 hours to 2.5 hours after the first dose of sumatriptan. Pharmacokinetic parameters for sumatriptan were evaluated by calculating geometric mean ratios (erenumab and sumatriptan/placebo and sumatriptan). Adverse events and anti-erenumab antibodies were also evaluated. Results A total of 34 subjects were randomized and included in the analysis. Least squares mean (standard error) time-weighted averages of mean arterial pressure were 87.4 (1.0) mmHg for the placebo and sumatriptan group and 87.4 (1.2) mmHg for the erenumab and sumatriptan group. Mean difference in mean arterial pressure between groups was −0.04 mmHg (90% confidence interval: −2.2, 2.1). Geometric mean ratio estimates for maximum plasma concentration of sumatriptan was 0.95 (90% confidence interval: 0.82, 1.09), area under the plasma concentration–time curve (AUC) from time 0 to 6 hours was 0.98 (90% confidence interval: 0.93, 1.03), and AUC from time 0 to infinity was 1.00 (90% confidence interval: 0.96, 1.05). No clinically relevant safety findings for co-administration of sumatriptan and erenumab were identified. Conclusion Co-administration of erenumab and sumatriptan had no additional effect on resting blood pressure or on pharmacokinetics of sumatriptan. Trial registration: ClinicalTrials.gov, NCT02741310.

The hemodynamic effects of rebaudioside A in healthy adults with normal and low-normal blood pressure

2008 ◽  
Vol 46 (7) ◽  
pp. S40-S46 ◽  
Author(s):  
K.C. Maki ◽  
L.L. Curry ◽  
M.C. Carakostas ◽  
S.M. Tarka ◽  
M.S. Reeves ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Healthy Adults ◽  
Normal Blood ◽  
Rebaudioside A ◽  
Normal Blood Pressure ◽  
Hemodynamic Effects

The hemodynamic effects on brachial and central blood pressure with the use of 5-hour ENERGY® drink in healthy adults

2014 ◽  
Vol 8 (4) ◽  
pp. e42
Author(s):  
Carolina Ojeda ◽  
Roshni Shah ◽  
Racheal Russell ◽  
Fernando Alcocer ◽  
Christian Machado ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Healthy Adults ◽  
Central Blood Pressure ◽  
Hemodynamic Effects

scholarly journals 636. A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Quadrivalent Dengue Vaccine (V181)

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S420-S421
Author(s):  
Kevin Russell ◽  
Richard E Rupp ◽  
Javier O Morales-Ramirez ◽  
Clemente Diaz-Perez ◽  
Charles P Andrews ◽  
...  
Keyword(s):  
Phase 1 ◽  
Healthy Adults ◽  
Controlled Study ◽  
Dengue Vaccine ◽  
Double Blind ◽  
Denv Serotypes ◽  
Medical Need ◽  
Tetravalent Vaccine ◽  
To Receive ◽  
Research Grant

Abstract Background Dengue (DENV) is a mosquito-borne virus with four serotypes causing substantial morbidity in tropical and subtropical areas worldwide. A dengue vaccine that can be given to both seronegative and seropositive populations remains an important unmet medical need. V181 is an investigational live, attenuated, quadrivalent dengue vaccine. Methods In this phase 1 double-blind, placebo-controlled study, the safety, tolerability, and immunogenicity of V181 in healthy adults were evaluated in two formulations: TV003 and TV005. TV005 has a 10-fold higher DENV2 component as compared to TV003. Two-hundred participants [~ 50% baseline flavivirus-experienced (BFE) and 50% baseline flavivirus-naive (BFN)] were randomized 2:2:1 to receive TV003, TV005, or placebo on Days 1 and 180. Immunogenicity against each of the four DENV serotypes was measured using a Virus Reduction Neutralization Test (VRNT60) after each vaccination and out to 1 year after the second dose. Results There were no discontinuations due to adverse events (AEs) or vaccine-related serious AEs. The most common AEs Days 1-28 after any TV003 or TV005 vaccination were rash, headache, fatigue, and myalgia. DENV VRNT60 seropositivity to 3 or 4 serotypes (i.e. tri-or tetravalent) was demonstrated in 92.6% of BFN TV003 participants, 74.2% of BFN TV005 participants, and 100% of the BFE participants at 6 months postdose 1 (PD1). Vaccine viremia, a measure of vaccine infectivity, was transiently detected from all four DENV types after the first dose of TV003 and TV005. Tri- or tetravalent vaccine-viremia was detected in 63.9 % and 25.6 % of BFN TV003 and TV005 participants, respectively, PD1. Compared to baseline, robust increases in VRNT60 GMTs were observed after the first dose of TV003 and TV005 in both flavivirus subgroups for all DENV serotypes and minimal increases were observed PD2. GMTs in the TV003 and TV005 BFE and BFN subgroups remained above the respective baselines and placebo at 1-year PD2. Conclusion Both formulations of V181 were generally well tolerated in healthy adults. Overall, viremia and immunogenicity were higher after TV003 as compared to TV005. These data support the continued development of the V181 TV003 formulation as a single-dose vaccine for the prevention of DENV disease. Disclosures Kevin Russell, MD, MTM&H, Merck & Co., Inc. (Employee, Shareholder) Richard E. Rupp, MD, Merck & Co., Inc. (Research Grant or Support) Clemente Diaz-Perez, MD, Merck & Co., Inc. (Research Grant or Support) Charles P. Andrews, MD, Merck & Co., Inc. (Research Grant or Support) Andrew W. Lee, MD, Merck & Co., Inc. (Employee, Shareholder) Tyler S. Finn, BA, Merck & Co., Inc. (Employee, Shareholder) Kara Cox, MS, Merck & Co., Inc. (Employee, Shareholder) Amy Falk Russell, MS, Merck & Co., Inc. (Employee, Shareholder) Margaret M. Schaller, BS, Merck & Co., Inc. (Employee, Shareholder) Jason C. Martin, PhD, Merck & Co., Inc. (Employee, Shareholder) Donna M. Hyatt, BA, Merck & Co., Inc. (Employee, Shareholder) Sabrina Gozlan-Kelner, MS, Merck & Co., Inc. (Employee, Shareholder) Androniki Bili, MD, MPH, Merck & Co., Inc. (Employee, Shareholder) Beth-Ann Coller, PhD, Merck & Co., Inc. (Employee, Shareholder)

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