A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation

Theravance Biopharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy; Opioid-induced Constipation

Treatments: Drug: Placebo; Drug: TD-1211

Study type: Interventional

Funder types: Industry

Identifiers

NCT01040637

0067

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females between 18 and 65 years of age, inclusive
• Healthy subjects and subjects with documented OIC on stable opioid regimen
• Willingness to stop all laxatives throughout the OIC screening and treatment period

Exclusion criteria

• Any clinically significant finding in healthy subjects
• Have participated in another clinical trial of an investigational drug 30 days prior to screening
• History of chronic constipation prior to opioid therapy in OIC subjects
• Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 10 patient groups, including a placebo group

TD-1211 dose level 1

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 dose level 2

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 dose level 3

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 dose level 4

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 OIC dose level 1

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 OIC dose level 2

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 OIC dose level 3

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 OIC dose level 4

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

TD-1211 OIC dose level 5

Experimental group

Description:

Ascending doses

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Placebo

Placebo Comparator group

Description:

Ascending doses

Treatment:

Drug: Placebo