Huntington's DiseasePhase 1NCT01521832
Escalating Dose Study in Healthy Volunteers With SEN0014196
A Phase 1 study testing SEN0014196 in people with Huntington's Disease, run by Siena Biotech S.p.A. at 1 site in United Kingdom.
Trial summary
This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics of single and multiple escalating doses of SEN0014196. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- SEN0014196
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to May 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects in Groups A to G and Groups I to K will be males of any ethnic origin between 18 and 55 years of age and with a body mass index (BMI) between 18 and 31 kg/m2 inclusive. Subjects in Groups H and L will be females of any ethnic origin between 18 and 65 years of age and with a body mass index (BMI) between 18 and 31 kg/m2 inclusive. All subjects will have a body weight greater than 50 kg. For Group H, women will be of non-childbearing potential, defined as follows: Female subjects 50 years of age or less must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicular stimulating hormone >18 mIU/mL and serum oestradiol <110 pmol/L), non-lactating and have a negative serum pregnancy test Female subjects of more than 51 years of age must be surgically sterile or post-menopausal (defined by a value of follicular stimulating hormone >18 mIU/mL and no spontaneous menstruation for at least one year before the first dose), non-lactating and have a negative serum pregnancy test.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations Note: congenital non-haemolytic hyperbilirubinaemia is not acceptable and serum potassium must be within the normal reference ranges (confirmed by repeat analysis).
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
Who cannot join
- Male subjects or Female subjects in Group H who are not, or whose partners are not willing to use appropriate contraception (such as condom) with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after the final dosing occasion. Female subjects in Group L who are not, willing to use appropriate contraception (such as condom) with spermicidal foam/gel/film/cream/suppository) from the time of screening until 3 months after the final dosing occasion, who have not had a menstrual period in the 28 days before the first dose.
- Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration (for female subjects, stable hormone replacement therapy is acceptable) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months, where possible this will be confirmed using The Over Volunteering Protection Service (TOPS).
- Subjects who have donated any blood, plasma or platelets in the 2 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the first dose administration.
Show all 19Show fewer
- Subjects with a significant history of drug allergy as determined by the Investigator.
- Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
- Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
- Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
- Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission. Or a history of substance abuse in the last 12 months prior to the start of the study.
- Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day.
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator.
- Subjects with, or with a family history of Huntington's Disease
- Subjects who have previously received histone deacetylase inhibitors e.g. vorinostat (Zolinza®) or have participated in a clinical trial using a histone deacetylase inhibitor.
- Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
- Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcF interval >450 msec (male) or greater than 470msec (female), or with sinus rhythm with PR interval <110 msec or >240 msec, confirmed by a repeat ECG.
- Subjects who, in the opinion of the Investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study Consisting of Single and Multiple Oral Dose Escalation to Determine, Safety, Tolerability and Pharmacokinetics of SEN0014196
This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics of single and multiple escalating doses of SEN0014196.
- Conditions
- Huntington's Disease
- Being tested
- SEN0014196
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEN0014196Drug
5 mg single oral dose
SEN0014196Drug
25 mg single oral dose
SEN0014196Drug
75 mg single oral dose
SEN0014196Drug
150 mg single oral dose
SEN0014196Drug
300 mg single oral dose
SEN0014196Drug
600 mg single oral dose
SEN0014196Drug
300 mg single oral dose (females)
SEN0014196Drug
100 mg multiple oral dose
SEN0014196Drug
300 mg multiple oral dose
SEN0014196Drug
100 mg BID multiple oral dose
SEN0014196Drug
100 mg BID multiple oral dose (females)
| Study group | Role | What they receive |
|---|---|---|
| Dose Group A | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group B | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group C | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group D | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group E | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group F | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group H | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group I | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group J | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group K | Experimental | Not described Receives: Drug: SEN0014196 |
| Dose Group L | Experimental | Not described Receives: Drug: SEN0014196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ascending single and multiple oral doses of SEN0014196 in healthy male and female subjects.
Vital signs, cardiovascular and neurological function, laboratory safety parameters. Type and frequancy of adverse events.
Measured: Up to 7 days after single dose and up to 10 days following multiple dose
Secondary outcomes (1)
Single and multiple dose pharmacokinetics of SEN0014196
Basic pharmacokinetic parameters (Cmax, AUC, accumulation ratio, gender differences).
Measured: Up to 96 hours following single dose and up to 48 hours following multiple dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
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 Huntington's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siena Biotech S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph A Chiesa, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521832
- Sponsor's protocol ID
- S015-001
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Westerberg G, Chiesa JA, Andersen CA, Diamanti D, Magnoni L, Pollio G, Darpo B, Zhou M. Safety, pharmacokinetics, pharmacogenomics and QT concentration-effect modelling of the SirT1 inhibitor selisistat in healthy volunteers. Br J Clin Pharmacol. 2015 Mar;79(3):477-91. doi: 10.1111/bcp.12513.
PubMed 25223836
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study Consisting of Single and Multiple Oral Dose Escalation to Determine, Safety, Tolerability and Pharmacokinetics of SEN0014196
- ClinicalTrials.gov ID
- NCT01521832
- Acronym / sponsor ID
- S015-001
- Conditions
- Huntington's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Siena Biotech S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 Jan 2012 (estimated)
- 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.
This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics of single and multiple escalating doses of SEN0014196.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose Group A | Experimental | Drug: SEN0014196 |
| Dose Group B | Experimental | Drug: SEN0014196 |
| Dose Group C | Experimental | Drug: SEN0014196 |
| Dose Group D | Experimental | Drug: SEN0014196 |
| Dose Group E | Experimental | Drug: SEN0014196 |
| Dose Group F | Experimental | Drug: SEN0014196 |
| Dose Group H | Experimental | Drug: SEN0014196 |
| Dose Group I | Experimental | Drug: SEN0014196 |
| Dose Group J | Experimental | Drug: SEN0014196 |
| Dose Group K | Experimental | Drug: SEN0014196 |
| Dose Group L | Experimental | Drug: SEN0014196 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects in Groups A to G and Groups I to K will be males of any ethnic origin between 18 and 55 years of age and with a body mass index (BMI) between 18 and 31 kg/m2 inclusive. Subjects in Groups H and L will be females of any ethnic origin between 18 and 65 years of age and with a body mass index (BMI) between 18 and 31 kg/m2 inclusive. All subjects will have a body weight greater than 50 kg. For Group H, women will be of non-childbearing potential, defined as follows: Female subjects 50 years of age or less must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicular stimulating hormone >18 mIU/mL and serum oestradiol <110 pmol/L), non-lactating and have a negative serum pregnancy test Female subjects of more than 51 years of age must be surgically sterile or post-menopausal (defined by a value of follicular stimulating hormone >18 mIU/mL and no spontaneous menstruation for at least one year before the first dose), non-lactating and have a negative serum pregnancy test.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations Note: congenital non-haemolytic hyperbilirubinaemia is not acceptable and serum potassium must be within the normal reference ranges (confirmed by repeat analysis).
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
Key exclusion criteria (19 listed)
- Male subjects or Female subjects in Group H who are not, or whose partners are not willing to use appropriate contraception (such as condom) with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after the final dosing occasion. Female subjects in Group L who are not, willing to use appropriate contraception (such as condom) with spermicidal foam/gel/film/cream/suppository) from the time of screening until 3 months after the final dosing occasion, who have not had a menstrual period in the 28 days before the first dose.
- Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration (for female subjects, stable hormone replacement therapy is acceptable) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months, where possible this will be confirmed using The Over Volunteering Protection Service (TOPS).
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 |
|---|---|---|
| SEN00141965 mg single oral dose | Drug | Dose Group A |
| SEN001419625 mg single oral dose | Drug | Dose Group B |
| SEN001419675 mg single oral dose | Drug | Dose Group C |
| SEN0014196150 mg single oral dose | Drug | Dose Group D |
| SEN0014196300 mg single oral dose | Drug | Dose Group E |
| SEN0014196600 mg single oral dose | Drug | Dose Group F |
| SEN0014196300 mg single oral dose (females) | Drug | Dose Group H |
| SEN0014196100 mg multiple oral dose | Drug | Dose Group I |
| SEN0014196300 mg multiple oral dose | Drug | Dose Group J |
| SEN0014196100 mg BID multiple oral dose | Drug | Dose Group K |
| SEN0014196100 mg BID multiple oral dose (females) | Drug | Dose Group L |
Primary outcome
Safety and tolerability of ascending single and multiple oral doses of SEN0014196 in healthy male and female subjects.
Time frame: Up to 7 days after single dose and up to 10 days following multiple dose
Vital signs, cardiovascular and neurological function, laboratory safety parameters. Type and frequancy of adverse events.
1 secondary outcome
Single and multiple dose pharmacokinetics of SEN0014196
Time frame: Up to 96 hours following single dose and up to 48 hours following multiple dose.
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 7 Feb 2012.
- Derived from this study: PubMed 25223836Westerberg G, Chiesa JA, Andersen CA, Diamanti D, Magnoni L, Pollio G, Darpo B, Zhou M. Safety, pharmacokinetics, pharmacogenomics and QT concentration-effect modelling of the SirT1 inhibitor selisistat in healthy volunteers. Br J Clin Pharmacol. 2015 Mar;79(3):477-91. doi: 10.1111/bcp.12513.
Related trials for Huntington's Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
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.
Joseph A Chiesa, MD principal investigator
Covance
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 SEN0014196 in people with Huntington's Disease, run by Siena Biotech S.p.A. 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 3 inclusion and 19 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 7 Feb 2012. 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. 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?
Safety and tolerability of ascending single and multiple oral doses of SEN0014196 in healthy male and female subjects. (time frame: Up to 7 days after single dose and up to 10 days following multiple dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521832, which also lists 1 linked publication.
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 7 Feb 2012.