Cognitive DisordersPhase 1NCT05486195
A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect
A Phase 1 study testing SDI-118 in people with Cognitive Disorders, run by AbbVie at 1 site in Belgium.
Trial summary
This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose of SDI-118 and an Assessment of Food Effect. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Disorders
- What is being tested?
- SDI-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Mar 2019to 11 Mar 2020
- Phase
- Phase 1
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, 18 to 50 years of age, inclusive.
- Non-smokers or abstinence from tobacco for at least 3 months prior to screening.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, with a minimum weight of 50 kg and maximum of 100 kg.
- Venous access sufficient to allow blood sampling as per the protocol.
- Agree to abstain from alcohol intake 24h before each administration of study drug, during the in-patient period of the study and 24 hours prior to all other out-patient clinic visits.
- Have given written informed consent approved by the relevant Ethics Committee (EC) governing the site.
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- In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the clinical study protocol restrictions and requirements.
- Subjects and their partners of childbearing potential must be willing to use 2 methods of contraception, one of which must be a barrier method, for the duration of the study and up to 90 days after the last dose.
- Specifically, Part B/PET related inclusion criteria:
- Adequate arterial circulation in both hands (Allen's test).
- MRI scan without clinically significant abnormalities.
- Specifically, Part C/FE related inclusion criteria:
- Subjects are not vegetarian and willing to eat a standardized high fat breakfast including butter and bacon.
Who cannot join
- History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal (GI), hepatic, or renal disorder.
- Positive Hepatitis B surface antigen (HBs Ag), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- Use of any medications (prescription or over-the-counter (OTC)), vitamin, mineral, herbal, and dietary supplements (including grapefruit products) within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
- Have an estimated Glomerular Filtration Rate (eGFR) <80 mL/min/1.73m2.
- Any of the following findings in the resting ECG:
- QTcF> 450 or < 300 msec at screening or baseline visit,
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- Notable resting bradycardia (HR < 40 bpm) or tachycardia (HR > 100 bpm) at screening or baseline visit,
- Personal or family history of congenital long QT syndrome or sudden death,
- Screening or baseline ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g. neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves),
- Evidence of atrial fibrillation, atrial flutter, Left Bundle Branch Block (LBBB), Wolf-Parkinson-White Syndrome, or cardiac pacemaker at screening or baseline visit (note: a first degree heart block with PR not exceeding 250 msec can be allowed).
- Specifically, Part B/PET related exclusion criteria:
- Previous inclusion in a research study and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as International Commission on Radiological Protection (ICRP) category IIb or above: no more than 1 mSv in addition to the natural background radiation in the previous 12 months including the dose from the study).
- Subject who fulfils any of the MRI contraindications on the standard radiography screening questionnaire (including the presence of ferromagnetic metal in the body or heart pacemaker).
- History of or suffers from claustrophobia or feels that they will be unable to lie still on their back in the PET camera for a period of 2 hours.
- Any known allergy to local anaesthetics or heparin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including Receptor Occupancy Measurements After Single Dose of SDI-118 and an Assessment of Food Effect
This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose of SDI-118 and an Assessment of Food Effect.
- Conditions
- Cognitive Disorders
- Being tested
- SDI-118, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDI-118Drug
SDI-118 Powder in Capsule
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| SDI-118 Dose 1 | Experimental | Not described Receives: Drug: SDI-118 |
| SDI-118 Dose 2 | Experimental | Not described Receives: Drug: SDI-118 |
| SDI-118 Dose 3 | Experimental | Not described Receives: Drug: SDI-118 |
| SDI-118 Dose 4 | Experimental | Not described Receives: Drug: SDI-118 |
| SDI-118 Dose 5 | Experimental | Not described Receives: Drug: SDI-118 |
| SDI-118 Dose 6 | Experimental | Not described Receives: Drug: SDI-118 |
| SDI-118 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Measured: 21 Days
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Measured: 21 Days
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values
Measured: 21 Days
Number of participants with temperature abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant temperature values
Measured: 21 Days
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Measured: 21 Days
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in physical examination.
Measured: 21 Days
Number of participants with routine neurological examination abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in neurological examination.
Measured: 21 Days
Number of participants with abnormalities on Profile of Mood States (Brief) and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in Profile of Mood States (Brief) values.
Measured: 21 Days
Number of participants with abnormalities on Bond-Lader-VAS and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in Bond-Lader VAS values.
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start14 Mar 2019
- Primary completion29 Jul 2019
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syndesi Therapeutics, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Jan deHoon, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486195
- Sponsor's protocol ID
- SYND001
- Other IDs
- 2018-004022-28, 2018
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Botermans W, Koole M, Van Laere K, Savidge JR, Kemp JA, Sunaert S, Duffy MM, Ramael S, Cesura AM, D'Ostilio K, Gossen D, Madsen TM, Lodeweyckx T, de Hoon J. SDI-118, a novel procognitive SV2A modulator: First-in-human randomized controlled trial including PET/fMRI assessment of target engagement. Front Pharmacol. 2023 Jan 17;13:1066447. doi: 10.3389/fphar.2022.1066447. eCollection 2022.
PubMed 36733374