Healthy SubjectsPhase 1NCT03372629
A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
A Phase 1 study testing ID-085 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United Kingdom.
Trial summary
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ID-085
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2018to 2 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent in the local language prior to any study-mandated procedure.
- Healthy male subjects for Part A, healthy male and female subjects for Part B aged between 18 and 55 years (inclusive) at screening.
- No clinically significant findings on physical examination at screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening.
Who cannot join
- History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Pregnant or lactating women.
- Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit - Clinical Pharmacology Services
Leeds, LS2 9LH
About this study
Official title: A Two-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of ID-085 in Healthy Subjects
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.
Read the detailed description
The study is designed in two parts, A and B.
Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose.
Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.
- Conditions
- Healthy Subjects
- Being tested
- ID-085, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID-085Drug
Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
Placebo oral capsuleDrug
Placebo capsules matching ID-085 capsules
| Study group | Role | What they receive |
|---|---|---|
| ID-085, single ascending dose (Part A) | Experimental | ID-085 administered at different single dose levels in a sequential manner, and in a maximum of 6 dose levels starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort) Receives: Drug: ID-085 |
| Placebo, single ascending dose (Part A) | Placebo comparator | Matched placebo administered as single ascending doses in parallel to ID-085 Receives: Drug: Placebo oral capsule |
| ID-085 multiple ascending dose (Part B) | Experimental | ID-085 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be either 10 or 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A Receives: Drug: ID-085 |
| Placebo, multiple ascending dose (Part B) | Placebo comparator | Matched placebo administered as single ascending doses in parallel to ID-085 Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in PQ/PR interval (ms)
ECG variables are to be recorded using a standard 12-lead ECG
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in QRS interval (ms)
ECG variables are to be recorded using a standard 12-lead ECG
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms)
ECG variables are to be recorded using a standard 12-lead ECG
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in RR interval (ms)
ECG variables are to be recorded using a standard 12-lead ECG
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in heart rate (bpm)
ECG variables are to be recorded using a standard 12-lead ECG
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in supine systolic blood pressure
mm Hg
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in supine diastolic blood pressure
mm Hg
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in supine pulse rate
bpm
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in body weight
kg
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Number of patients with treatment-emergent AEs and SAEs for each treatment period
Treatment-emergent AEs and treatment-emergent serious AEs
Measured: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
Measured: up to Day 3 (Part A), up to Day 10 (Part B)
Time to reach Cmax (tmax)
Measured: up to Day 3 (Part A), up to Day 10 (Part B)
Terminal half-life [t(1/2)]
Measured: up to Day 3 (Part A), up to Day 10 (Part B)
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Measured: up to Day 3 (Part A), up to Day 10 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start12 Jan 2018
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372629
- Sponsor's protocol ID
- ID-085-101
- Other IDs
- 2017-004124-30, 2017
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of ID-085 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03372629
- Acronym / sponsor ID
- ID-085-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.
Detailed description
The study is designed in two parts, A and B.
Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose.
Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ID-085, single ascending dose (Part A) | Experimental | Drug: ID-085ID-085 administered at different single dose levels in a sequential manner, and in a maximum of 6 dose levels starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort) |
| Placebo, single ascending dose (Part A) | Placebo comparator | Drug: Placebo oral capsuleMatched placebo administered as single ascending doses in parallel to ID-085 |
| ID-085 multiple ascending dose (Part B) | Experimental | Drug: ID-085ID-085 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be either 10 or 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A |
| Placebo, multiple ascending dose (Part B) | Placebo comparator | Drug: Placebo oral capsuleMatched placebo administered as single ascending doses in parallel to ID-085 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent in the local language prior to any study-mandated procedure.
- Healthy male subjects for Part A, healthy male and female subjects for Part B aged between 18 and 55 years (inclusive) at screening.
- No clinically significant findings on physical examination at screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening.
Key exclusion criteria (5 listed)
- History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Pregnant or lactating women.
- Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID-085Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg | Drug | ID-085 multiple ascending dose (Part B), ID-085, single ascending dose (Part A) |
| Placebo oral capsulePlacebo capsules matching ID-085 capsules | Drug | Placebo, multiple ascending dose (Part B), Placebo, single ascending dose (Part A) |
Primary outcome
Changes from baseline in PQ/PR interval (ms)
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
Changes from baseline in QRS interval (ms)
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms)
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
Changes from baseline in RR interval (ms)
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
Changes from baseline in heart rate (bpm)
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
Changes from baseline in supine systolic blood pressure
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
mm Hg
Changes from baseline in supine diastolic blood pressure
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
mm Hg
Changes from baseline in supine pulse rate
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
bpm
Changes from baseline in body weight
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
kg
Number of patients with treatment-emergent AEs and SAEs for each treatment period
Time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Treatment-emergent AEs and treatment-emergent serious AEs
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Time to reach Cmax (tmax)
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Terminal half-life [t(1/2)]
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Time frame: up to Day 3 (Part A), up to Day 10 (Part B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ID-085 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in PQ/PR interval (ms) (time frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.