Succinate Salt Version of GSK961081 for Healthy Volunteers

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: GSK961081 matching placebo; Drug: GSK961081

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550225

MAB108115

Details and patient eligibility

About

Salt Bridging study for GSK961081

Enrollment: 18 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 8 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 4

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 5

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 6

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 7

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081

Sequence 8

Experimental group

Description:

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.

Treatment:

Drug: GSK961081 matching placebo

Drug: GSK961081