Clinical trials: Single Dose
Healthy
A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood
The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.
- Trial name
- NCT03907280
- Testing
- BI 1265162 (T1), BI 1265162 (T2), BI 1265162 (R)
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hemophilia B
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061).
- Trial name
- NCT03569891
- Testing
- AAV5-hFIXco-Padua, Factor IX (FIX)
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 67 people
- Sponsor
- CSL Behring
Healthy
Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers
To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances
- Trial name
- NCT02264093
- Testing
- Propranolol, Talsaclidine
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infection, Infection, Human Immunodeficiency Virus
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body.
- Trial name
- NCT00386347
- Testing
- GSK364735 oral solution and oral tablets
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Participants
A Study to Evaluate the PK/PD and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
To evaluate the pharmacokinetic characteristics of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants.
- Trial name
- NCT07913048
- Testing
- KL0011034 injection
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Benign Prostatic Hyperplasia
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects
- Trial name
- NCT07444385
- Testing
- AD-116, AD-1161
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Healthy Volunteer
Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of orally administered lomitapide in healthy male Japanese and Caucasian subjects with elevated LDL-C.
- Trial name
- NCT01760187
- Testing
- lomitapide
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Healthy
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets…
- Trial name
- NCT02548806
- Testing
- Clonidine MBT 50µg, Clonidine MBT 100µg, Catapres 100μg
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valerio Therapeutics
Healthy Volunteers
A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects.
- Trial name
- NCT02770404
- Testing
- Nafithromycin
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants
The purpose of this study is to assess the rate and extent of absorption of JNJ63623872 following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept single agent tablet formulations compared to the…
- Trial name
- NCT03023852
- Testing
- JNJ-63623872, Oseltamivir
- Where
- Belgium
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV
Healthy Volunteers
A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804
The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.
- Trial name
- NCT01479647
- Testing
- PH-797804
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.
- Trial name
- Japan SMAD (NCT01318655)
- Testing
- NKTR-118
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteer
A Study of DISC-3405 in Healthy Volunteers
This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.
- Trial name
- NCT06050915
- Testing
- DISC-3405
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Disc Medicine, Inc
Beta-Thalassemia, Thalassemia
A Safety and Efficacy Study Evaluating CTX001 in Participants With Transfusion-Dependent β-Thalassemia
This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in participans with transfusion-dependent β-thalassemia (TDT).
- Conditions
- Beta-Thalassemia, Thalassemia, Genetic Diseases, Inborn, Hematologic Diseases
- Trial name
- NCT03655678
- Testing
- CTX001
- Where
- 14 sites in United States, Canada and 3 more
- Volunteers
- 59 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Volunteer
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants
This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants.
- Trial name
- NCT02015715
- Testing
- RO6864018
- Where
- 2 sites in Singapore
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood
The main objective of this trial is to investigate the relative bioavailability of BI 730357 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as…
- Trial name
- NCT03782987
- Testing
- BI 730357, Itraconazole
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2).
- Trial name
- NCT03682484
- Testing
- MA-0211
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Obesity&T2D
Bioequivalence Study of GZR18 Injection Before and After CMC Change
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
- Trial name
- NCT07355738
- Testing
- GZR18 injection A, GZR18 injection B
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Chronic Neuropathic Pain
Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain…
- Trial name
- NCT06980948
- Testing
- ST-503
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Sangamo Therapeutics
Pulmonary Arterial Hypertension
Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
The development of selexipag for intravenous administration will be useful to avoid treatment interruptions in patients with pulmonary arterial hypertension (PAH) already treated with selexipag administered orally as tablets…
- Trial name
- NCT03187678
- Testing
- i.v. selexipag, oral selexipag (Uptravi)
- Where
- 8 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Actelion
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