HealthyPhase 1NCT02217826
Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173
A Phase 1 study testing DG3173, Saline and Octreotide in people with Healthy, run by Aspireo Pharmaceuticals Limited.
Trial summary
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DG3173, Saline and Octreotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ethnic origin: Caucasian
- Body Mass Index (BMI): 19-27 kg/m2 inclusive
- Medical history without clinically relevant pathologies
- Physical examination parameters without signs of clinically relevant pathologies
- Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms
- Values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator (in particular for alanine transaminase, aspartate transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, bilirubin, and α-amylase)
- Subjects with partner of child bearing potential must be willing to practice a medically approved method of contraception (e.g., condom in combination with hormonal contraception or intrauterine device or a diaphragm with spermicide after the first drug administration and for one month after participation in the study or are vasectomized since > 6 months or has a partner being sterilized since > 6 months
- Having given written informed consent before any study-related activities are carried out
Who cannot join
- Evidence of clinically relevant pathology or disease
- Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
- Mental handicap
- Legal incapacity
- Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
- Chronic diarrhea or other acute or chronic gastrointestinal disorders
Show all 23Show fewer
- Presence or history of endocrine disorders
- Presence or history of gallstone disease
- Known hypersensitivity to the study drug or constituent of the study drug
- History of any relevant allergy, especially drug and/or food allergies
- Strict vegetarian
- Regular treatment with medications during three months prior to randomization
- Receipt of any prescription or non-prescription medication, including multi vitamin preparations within 14 days prior randomization and for the duration of the study
- Use of St. John's Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization
- Participation in a clinical study within 30 days prior to randomization
- Donation of blood (450 ml) within 60 days prior to randomization
- Receipt of blood, blood products or plasma derivates one year prior to randomization
- Regular smoking of >5 cigarettes per day within the past three months
- Any history of alcohol abuse or drug addiction
- Known consumer of drugs of abuse
- Known to be infected with HBsAg, anti-HCV, or anti-HIV1 and HIV2
- Consumption of abnormal quantities of coffee or tea (i.e., more than 5 cups per day [1 cup = 150 ml])
- Any disease which in the Investigator's opinion would exclude the subject from the study.
About this study
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control. The main purpose of the study was to investigate the effects of each treatment on the control of plasma glucose as well as the secretion of insulin and glucagon following a standard meal.
- Conditions
- Healthy
- Being tested
- DG3173, Saline, Octreotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DG3173Drug
SalineDrug
OctreotideDrug
| Study group | Role | What they receive |
|---|---|---|
| DG3173 | Experimental | Not described Receives: Drug: DG3173; Drug: Saline; Drug: Octreotide |
| Saline | Placebo comparator | Not described Receives: Drug: DG3173; Drug: Saline; Drug: Octreotide |
| Octreotide | Active comparator | Not described Receives: Drug: DG3173; Drug: Saline; Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of glucose, insulin and glucagon in plasma.
Measured: Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspireo Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217826
- Sponsor's protocol ID
- DG3173-I-003
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173
- ClinicalTrials.gov ID
- NCT02217826
- Acronym / sponsor ID
- DG3173-I-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aspireo Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Primary completion
- Apr 2014 (actual)
- First posted
- 15 Aug 2014 (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.
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control. The main purpose of the study was to investigate the effects of each treatment on the control of plasma glucose as well as the secretion of insulin and glucagon following a standard meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DG3173 | Experimental | Drug: DG3173, Drug: Saline, Drug: Octreotide |
| Saline | Placebo comparator | Drug: DG3173, Drug: Saline, Drug: Octreotide |
| Octreotide | Active comparator | Drug: DG3173, Drug: Saline, Drug: Octreotide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ethnic origin: Caucasian
- Body Mass Index (BMI): 19-27 kg/m2 inclusive
- Medical history without clinically relevant pathologies
- Physical examination parameters without signs of clinically relevant pathologies
- Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms
Key exclusion criteria (23 listed)
- Evidence of clinically relevant pathology or disease
- Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
- Mental handicap
- Legal incapacity
- Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
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 |
|---|---|---|
| DG3173 | Drug | DG3173, Octreotide, Saline |
| Saline | Drug | DG3173, Octreotide, Saline |
| Octreotide | Drug | DG3173, Octreotide, Saline |
Primary outcome
Concentration of glucose, insulin and glucagon in plasma.
Time frame: Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration
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 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DG3173, Saline and Octreotide in people with Healthy, run by Aspireo Pharmaceuticals Limited.
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 8 inclusion and 23 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 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Concentration of glucose, insulin and glucagon in plasma. (time frame: Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration). 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 Aug 2014.