Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects

• Sponsor: Idorsia Pharmaceuticals Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02708004
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: ACT-132577; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Single-center, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACT-132577 3 different dose levels	Drug: ACT-132577; Formulated in capsules in 2 different strengths; 2 capsules per day
Placebo Comparator: Placebo Matching active drug	Other: Placebo; Matching active drug

Outcome Measures

Primary Outcome Measures

1. Body weight [from Day 1 to Day 9]

   Change from baseline

Other Outcome Measures

1. Treatment-emergent Adverse Events [From Day 1 up to End-of-Study (i.e. for at least 25 days)]

   Number of subjects with Adverse Events

2. Treatment-emergent Serious Adverse Events [From Screening (Day -3) up to Follow-up (i.e. for at least 49 days)]

   Number of subjects with Serious Adverse Events

3. Glomerular filtration rate (GFR) [At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9]

   Change from baseline to each scheduled timepoint

4. Fractional sodium excretion in 24 h urine samples [mmol per day] [At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9]

   Fractional excretion will be calculated as the clearance of sodium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint

5. Fractional lithium excretion in 24 h urine samples [mmol per day] [At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9]

   Fractional excretion will be calculated as the clearance of lithium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed informed consent

• Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests

• Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening

Exclusion Criteria:

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site Lausanne	Lausanne		Switzerland	1011

Sponsors and Collaborators

• Idorsia Pharmaceuticals Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Idorsia Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT02708004
• Other Study ID Numbers: AC-080-102
• First Posted: Mar 15, 2016
• Last Update Posted: Jul 10, 2018
• Last Verified: Jul 1, 2018

Study Results

No Results Posted as of Jul 10, 2018