A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation

Inclusion Criteria:

• stable dose of opioids for at least 12 weeks before screening visit
• less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
• willing to stop laxatives and other bowel treatments; rescue laxative allowed

Exclusion Criteria:

• Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
• Have participated in another clinical trial of an investigational drug 30 days prior to screening
• History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
• History of chronic constipation prior to opioid therapy
• Females who are pregnant or breast feeding
• Have any condition that may affect drug absorption (e.g. previous GI surgery)

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.