Succinate Salt Version of GSK961081 for Healthy Volunteers
Phase 1
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: GSK961081 matching placebo
- Registration Number
- NCT00550225
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
Salt Bridging study for GSK961081
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
- Healthy adult males or female aged between 18 and 50 years.
- Body mass index within the range 19-29.9 kilograms/metre2
- Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
- Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.
Exclusion criteria:
- Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
- History of respiratory disease
- Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
- Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
- Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
- Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
- Infected with the Hepatitis B, Hepatitis C, or HIV virus
- Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 GSK961081 matching placebo In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4. Sequence 4 GSK961081 matching placebo In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 6 GSK961081 matching placebo In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4. Sequence 5 GSK961081 matching placebo In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4. Sequence 7 GSK961081 In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 3 GSK961081 matching placebo In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 7 GSK961081 matching placebo In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 8 GSK961081 matching placebo In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 1 GSK961081 matching placebo In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4. Sequence 5 GSK961081 In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4. Sequence 6 GSK961081 In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4. Sequence 1 GSK961081 In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4. Sequence 2 GSK961081 In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4. Sequence 4 GSK961081 In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 3 GSK961081 In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4. Sequence 8 GSK961081 In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
- Primary Outcome Measures
Name Time Method FEV1 at intervals during the 10 week study Cardiac monitoring at intervals during the 10 week study
- Secondary Outcome Measures
Name Time Method PK parameters at intervals during the 10week study Plasma concentrations of GSK961081 at intervals during the 10 week study
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom