Advertisement

Topics

A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects

2016-09-29 23:08:21 | BioPortfolio

Summary

The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults. Pharmacodynamic effects (through a battery of Central Nervous System tests) were also assessed.

Description

The study consisted of ascending dose groups; each dose group was investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo). In addition, the study included a biocomparison part (dose group 2), an absolute bioavailability part (dose group 4), and a mass balance / metabolism part (dose group 3).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Conditions

Healthy Subjects

Intervention

ACT-541468 (Formulation A), ACT-541468 (Formulation B), Placebo (Formulation A), Placebo (Formulation B), 14C-labeled ACT-541468, Placebo tracer

Location

Investigator Site
Leiden
Netherlands
2333 CL

Status

Completed

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-29T23:08:21-0400

Clinical Trials [4907 Associated Clinical Trials listed on BioPortfolio]

Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants

The purpose of this study is to evaluate in a double-blinded fashion the taste and overall acceptability profile of different ALS-008176 oral liquid formulations as compared to the referen...

Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

The primary objective of this study is to assess the effect of ACT-541468 on a measure of sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with insomnia di...

A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam

The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics or PK (i.e. how long and how much a compound is present in the blood) of ACT-541468 and...

AZD9056 Relative Bioavailability Study

The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.

A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new...

PubMed Articles [1887 Associated PubMed Articles listed on BioPortfolio]

Preparation, characterization, and pharmacokinetics in swine of a florfenicol enteric formulation prepared using hot-melt extrusion technology.

The objective of this work was to manufacture an enteric formulation of florfenicol (FF) using hot-melt extrusion (HME) technology and to evaluate its in vitro dissolution and in vivo pharmacokinetics...

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study.

Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation...

Copper-CX-5461: A novel liposomal formulation for a small molecule rRNA synthesis inhibitor.

CX-5461 is currently in Phase I/II clinical trials for advanced hematologic malignancies and triple negative or BRCA-deficient breast cancer. The compound is currently administered to patients intrave...

Therapeutic Effects of Standardized Formulation of Stachys lavandulifolia Vahl on Primary Dysmenorrhea: A Randomized, Double-Blind, Crossover, Placebo-Controlled Pilot Study.

In Iranian folklore medicine, boiled extract of Stachys lavandulifolia Vahl is reputed to have therapeutic effects in painful disorders. This study evaluated the efficacy of the standardized formulati...

Comparative pharmacokinetics of two florfenicol formulations following intramuscular and subcutaneous administration to sheep.

OBJECTIVE To compare the pharmacokinetics of 2 commercial florfenicol formulations following IM and SC administration to sheep. ANIMALS 16 healthy adult mixed-breed sheep. PROCEDURES In a crossover st...

Medical and Biotech [MESH] Definitions

A type of viscous polysaccharide that is secreted from PLANTS. It has natural properties that are useful in the formulation of ADHESIVES.

A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.

Disorders in which phagocytic cells cannot kill ingested bacteria; characterized by frequent recurring infection with formulation of granulomas.

A field of biological research combining engineering in the formulation, design, and building (synthesis) of novel biological structures, functions, and systems.

Insulin formulation containing substance which delays or retards time period of the absorption of insulin.

More From BioPortfolio on "A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial