Double-blind, Randomised Study of A3384 in BAM/BAD

Albireo

Status and phase: Completed; Phase 2

Conditions: Bile Acid Malabsorption

Treatments: Drug: A3384

Study type: Interventional

Funder types: Industry

Identifiers

NCT02078856

A3384-001

Details and patient eligibility

About

The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea
• Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable

Exclusion criteria

• Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
• Patient needs medications prohibited as specified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 3 patient groups, including a placebo group

A3384 Low dose

Experimental group

Description:

Administered twice daily for the duration of the study

Treatment:

Drug: A3384

A3384 High dose

Experimental group

Description:

Administered twice daily for the duration of the study

Treatment:

Drug: A3384

Placebo

Placebo Comparator group

Description:

Administered twice daily for the duration of the study

Treatment:

Drug: A3384