Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: GSK233705

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500461

AC2106213

Details and patient eligibility

About

GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.

Enrollment: 9 patients

Sex: Male

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects;
• Between the ages of 18-55 years, inclusive
• Body mass index within the range 18.0 to 30.0 kg/m2.
• Non-smokers
• Adequate venous access for intermittent cannulation
• A signed and dated written informed consent is obtained from the subject
• The subject is capable of giving informed consent
• Available to complete the study

Exclusion criteria

• Any clinically important abnormality identified in the following: at the screening medical assessment
• A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
• A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
• A mean heart rate outside the range of 40-90 bpm at screening.
• History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
• The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
• The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
• The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
• The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
• The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Subjects receiving GSK233705

Experimental group

Description:

Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.

Treatment:

Drug: GSK233705