Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects
NCT ID: NCT03165097
Last Updated: 2019-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2017-07-07
2018-12-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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ACT-709478
40 subjects will receive multiple doses of ACT-709478 at the planned dose levels of 30, 60, 100, and 200 mg.
Each dose level will be investigated in a new cohort of 10 healthy male and female subjects (4 male subjects on active drug and 1 on placebo, 4 female subjects on active drug and 1 on placebo) undergoing one treatment period with a once daily dosing scheme.
ACT-709478
Hard gelatine capsules for oral administration
Placebo
Matched placebo administered accordingly
Placebo
Placebo capsules matching ACT-709478 capsules
Midazolam
4 mg taken by mouth on Day 1 of the corresponding cohort
Midazolam
Midazolam oral solution (2 mg/mL) applied with a syringe
ACT-709478 combined with Midazolam
On Day 22 and Day 30, midazolam (4 mg) and ACT-709478 (60 mg or 100 mg) to be co-administered.
ACT-709478 combined with midazolam
Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe
Interventions
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ACT-709478
Hard gelatine capsules for oral administration
Placebo
Placebo capsules matching ACT-709478 capsules
Midazolam
Midazolam oral solution (2 mg/mL) applied with a syringe
ACT-709478 combined with midazolam
Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe
Eligibility Criteria
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Inclusion Criteria
* Healthy male and female subjects aged between 18 and 55 years (inclusive) at screening
* Negative serum pregnancy tests at screening and negative urine pregnancy test at Day -1 for women and agreement to use 2 reliable methods of contraception for at least 3 months after last study drug administration
* Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening
* Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 minutes in the supine position at screening and on Day -1
* Healthy on the basis of physical examination, cardiovascular, ophthalmological, neurological assessments and laboratory tests
Exclusion Criteria
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments
* QT interval corrected with Fridericia's formula (QTcF) \> 450 ms (using the ECG machine HR correction method) at screening and on Day -1
* Treatment with another investigational treatment within 2 months or 5 t1/2 (whichever is the longest) prior to screening or participation in more than four investigational treatment studies within 1 year prior to screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
18 Years
55 Years
ALL
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Parexel
Berlin, , Germany
Countries
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References
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Richard M, Kaufmann P, Ort M, Kornberger R, Dingemanse J. Multiple-Ascending Dose Study in Healthy Subjects to Assess the Pharmacokinetics, Tolerability, and CYP3A4 Interaction Potential of the T-Type Calcium Channel Blocker ACT-709478, A Potential New Antiepileptic Drug. CNS Drugs. 2020 Mar;34(3):311-323. doi: 10.1007/s40263-019-00697-1.
Other Identifiers
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2017-000336-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AC-083-102
Identifier Type: -
Identifier Source: org_study_id