Clinical trials: Healthy Male and Female Subjects
Healthy Volunteers, Renal Impairment
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans.
- Trial name
- NCT02341599
- Testing
- MK-6183
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy
Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects
The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without…
- Trial name
- NCT02203500
- Testing
- Lacidipine, Telmisartan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Chronic Kidney Disease
Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK).
- Trial name
- NCT04532918
- Testing
- Verinurad, Allopurinol, Cyclosporine
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers, Hepatic Impairment
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control…
- Trial name
- NCT05814926
- Testing
- GP681
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Healthy
A Safety, Tolerability, PD and PK Study in Healthy Adults
The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
- Trial name
- NCT02211625
- Testing
- Open-label TRV734 125 mg, TRV734 blinded, Oxycodone IR 10 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Trevena Inc.
Renal Impairment
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and…
- Trial name
- NCT03235076
- Testing
- BAY1101042
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Healthy Volunteers, Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.
- Trial name
- NCT04909723
- Testing
- NOV-001, NB1000S, NB2000P
- Where
- 20 sites in United States, Canada
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novome Biotechnologies Inc
Healthy Volunteers
Study of AC0058TA in Healthy Male and Female Subjects
AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in inhibition of inflammatory cytokine production in…
- Trial name
- NCT02847325
- Testing
- AC0058TA
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ACEA Therapeutics, Inc.
Smoking Cessation
Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch
An investigation on the cumulative skin irritation potential of a newly developed 25 mg nicotine patch. Evaluation of skin irritation of a newly developed 25 mg nicotine transdermal patch
- Trial name
- NCT00967174
- Testing
- Nicotine Patch, SLS Comparator Patch
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- McNeil AB
Gastroparesis
A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040
Motilin is a peptide whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach).
- Trial name
- NCT00562848
- Testing
- GSK962040
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in…
- Trial name
- NCT01947153
- Testing
- Metformin, Linagliptin
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects
A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female…
- Trial name
- NCT03502902
- Testing
- HEC 68498
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual…
- Trial name
- NCT03629054
- Testing
- Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination), Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Respiratory Syncytial Virus Infections
Safety, Tolerability and PK Study of AK0529 in Healthy Human
The purpose of this study is to assess the safety, tolerability and PK of single and multiple ascending dose of AK0529 when administered orally in healthy subjects
- Trial name
- NCT02297594
- Testing
- AK0529
- Where
- Australia
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
Healthy
This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)
The primary objective of this trial is to assess the effect of BI 409306 on the QT/QTc interval in healthy male and female volunteers as measured by the QTcF change from baseline compared with placebo.
- Trial name
- NCT03934203
- Testing
- BI 409306, Moxifloxacin
- Where
- Germany
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment
Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
- Trial name
- NCT01934166
- Testing
- Nalmefene 18 mg
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Pharmacology, Clinical
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose of 10 mg Immediate Release Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure).
- Trial name
- NCT04320771
- Testing
- Neladenoson bialanate (BAY 1067197)
- Where
- 2 sites in Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body
The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.
- Trial name
- NCT04390568
- Testing
- Spesolimap
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus
A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
Primary Objective: To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.
- Trial name
- NCT03174548
- Testing
- Sotagliflozin (SAR439954)
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sanofi