AzTrials
AzTrials

Ulcerative ColitisPhase 1NCT03071081

Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects

A Phase 1 study testing TOP1288 in people with Ulcerative Colitis, run by Topivert Pharma Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluates the safety and tolerability of TOP1288 oral single ascending and multiple doses in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis
What is being tested?
TOP1288
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteUnited Kingdom
Study dates
8 Feb 2017to 2 Jun 2017
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject is a healthy male, aged between 18 and 55 years of age (inclusive) at Screening.
  • Subject has a body mass index (BMI) of between 18.0 and 29.9 kg/m2 (inclusive), with a body weight of at least 50 kg at Screening.
  • Subject is in good physical and mental health in the opinion of the Investigator.
  • Subject has clinical laboratory test results within the reference ranges of the testing laboratory unless results outside the reference ranges are deemed not clinically significant by the Investigator at Screening and Day -1.
  • Subject has a supine blood pressure and pulse rate within the normal range after 5 minutes' rest (systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg, pulse rate: 40 to 90 beats per minute) at Screening and Day -1.
  • Subjects must be willing to comply with the contraception restrictions of the protocol for this study.
  • Subject has regular bowel opening of usually 1 motion per day of normal consistency.

Who cannot join

  • Subject has participated in another study of an investigational medication (or a medical device) within the last 3 months or 5 half-lives of the investigational medication, whichever is longer, prior to the first day or dosing.
  • Subject has made a blood donation (> 400 mL) or had a comparable blood loss (> 350 mL) within the last 3 months prior to first administration of study drug.
  • Subject tests positive for human immunodeficiency virus (HIV)-1/2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies at Screening.
  • Subject has a history of alcohol and/or drug abuse.
  • Subject has an alcohol consumption of more than 21 units of alcohol per week.
  • Subject tests positive for alcohol and/or drugs (urine tests) at Screening or admission.
Show all 28Show fewer
  • Subject has received any prescription or non-prescription medications, including over-the-counter medications, nutraceuticals (e.g., St. John's Wort, ginseng, kava kava, Ginkgo biloba and melatonin), foods or beverages containing grapefruit and vitamin supplements within 14 days prior to admission (Day -1) or nutraceuticals containing caffeine- or xanthine-related substances within 72 hours prior to admission (Day -1). Foods or beverages containing Seville-type (sour) oranges, or poppy seeds are also excluded within this time period.
  • The subject has a history of daily consumption of 5 or more cups of coffee or tea.
  • Subject has a known hypersensitivity to any components of the study drug.
  • Subject has any history of any clinically significant acute or chronic condition affecting the colon and/or rectum and/or anus, including haemorrhoids and irritable bowel syndrome, sufficient to cause symptoms and/or that in the judgement of the PI and the Sponsor's study Physician/Medical Monitor would interfere with the subject's participation in the study.
  • Any findings on pre-dose endoscopy that in the PI's judgement would interfere with subject participation in the study.
  • Subject has acute or chronic condition affecting GI motility such as constipation or diarrhoea that would, in the judgement of the PI and the Sponsor's study Physician/Medical Monitor, interfere with the subject's participation in the study
  • Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischaemic heart disease, transient ischaemic attacks, stroke and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
  • Subject has an active infection (e.g., sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalisation or requiring parenteral antibiotic treatment) within 6 weeks prior to study drug administration.
  • Subject has a history of positive tuberculosis test or evidence of possible tuberculosis or latent tuberculosis infection at Screening (interferon gamma release assay testing) that cannot be attributed to a prior Bacillus Calmette-Guérin inoculation.
  • Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
  • Subject has any of the following haematology values at Screening or Day -1:
  • Haemoglobin, < 13 g/dL.
  • Absolute neutrophil count < 1.5 x 109/L (< 1500/μL).
  • Subject has a 12-lead electrocardiogram (ECG) with results considered to be potentially clinically significant, e.g., QTcF > 450 ms, bundle branch block, evidence of myocardial ischaemia, at Screening or Day -1.
  • Subject has an abnormality in the ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study.
  • Subject has renal or liver impairment at Screening or Day -1, defined as:
  • Serum creatinine level ≥ 135 μmol/L, or
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2 x upper limit of normal, or
  • Alkaline phosphate and/or bilirubin > 1.5 x upper limit of normal (an isolated bilirubin 1.5 x upper limit of normal is acceptable if bilirubin is fractionated and direct bilirubin is < 35%).
  • Subject has active neoplastic disease or history of any neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care).
  • Subject has any other acute or chronic illness which, in the opinion of the Investigator or Sponsor's study Physician/Medical Monitor, could pose a threat or harm to the subject's participation in the study.
  • The subject has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 2 weeks prior to admission to the study centre (Day -1).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • PAREXEL Early Phase Clinical Unit

    London

Other trials in United Kingdom

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy Volunteers

This study evaluates the safety and tolerability of TOP1288 oral single ascending and multiple doses in healthy subjects.

Being tested
TOP1288, Placebo to TOP1288
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOP1288Drug

    Oral TOP1288

  • Placebo to TOP1288Drug

    Oral placebo to TOP1288

Study groups in NCT03071081
Study groupRoleWhat they receive
TOP1288 200mg BIDExperimental1 day dosing
Receives: Drug: TOP1288
Placebo to TOP1288 200mg BIDPlacebo comparator1 day dosing
Receives: Drug: Placebo to TOP1288
TOP1288 1g BIDExperimental1 day dosing
Receives: Drug: TOP1288
Placebo to TOP1288 1g BIDPlacebo comparator1 day dosing
Receives: Drug: Placebo to TOP1288
TOP1288 Xg (where X is <=1g) BIDExperimental7 days dosing
Receives: Drug: TOP1288
Placebo to TOP1288 XgPlacebo comparator7 days dosing
Receives: Drug: Placebo to TOP1288

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (AEs)

    As measured by adverse events

    Measured: To 7 days after last dose

  2. Safety (ECGs)

    As measured by ECGs

    Measured: To 7 days after last dose

  3. Safety (vital signs)

    As measured by vital signs

    Measured: To 7 days after last dose

  4. Safety (clinical lab tests)

    As measured by clinical laboratory tests

    Measured: To 7 days after last dose

Secondary outcomes (11)

  1. Pharmacokinetic profile Cmax

    Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)

    Measured: 0-48 hours

  2. Pharmacokinetic profile AUC

    Area under the plasma concentration-curve (AUC)

    Measured: 0-48 hours

  3. Pharmacokinetic profile AUC0-12h

    AUC from time zero to 12 h (AUC0-12h)

    Measured: 0-12 hours

  4. Pharmacokinetic profile AUC0-24h

    AUC from time zero to 24 h (AUC0-24h)

    Measured: 0-24 hours

  5. Pharmacokinetic profile AUC0-t

    AUC from time zero to the last measurable concentration (AUC0-t)

    Measured: 0-48 hours

  6. Pharmacokinetic profile Racc

    Accumulation ratio of the AUC (Racc) (multiple dose part only)

    Measured: 0-48 hours

  7. Pharmacokinetic profile tmax

    Time to reach maximum concentration, taken directly from the individual concentration-time curve (tmax)

    Measured: 0-48 hours

  8. Pharmacokinetic profile t½

    Terminal half-life (t½)

    Measured: 0-48 hours

  9. Pharmacokinetic profile λz

    Terminal elimination rate constant (λz)

    Measured: 0-48 hours

  10. Pharmacokinetic profile CL/F

    Apparent total clearance from plasma after oral administration (CL/F)

    Measured: 0-48 hours

  11. Pharmacokinetic profile Vz/F

    Volume of distribution of the absorbed fraction (Vz/F)

    Measured: 0-48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2017
  2. Study start8 Feb 2017
  3. Primary completion2 Jun 2017
  4. Study completion2 Jun 2017

Resources

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
Parallel groups
Model description
3 dose groups (2 arms per dose group)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03071081
Sponsor's protocol ID
TOP1288-TV-03
Status last verified
Sep 2018
First submitted
20 Feb 2017
Last updated
20 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TOP1288 in people with Ulcerative Colitis, run by Topivert Pharma 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 7 inclusion and 28 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 20 Sep 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?

Safety (AEs) (time frame: To 7 days after last dose). The study lists 4 primary outcomes in all. 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 NCT03071081.

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 20 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in