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

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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

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

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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