HypertensionPhase 1NCT01033318
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)
A Phase 1 study testing MK1809 and Comparator: Losartan in people with Hypertension, run by Merck Sharp & Dohme LLC.
Trial summary
The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- MK1809 and Comparator: Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2007to 19 Jun 2008
- 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
- Part 1:
- Nonsmoker for at least 6 months
- Body Mass Index (BMI) less than or equal to 29 kg/m2
- In overall good health
- Part 2:
- Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2
- In overall good health (patients with hypertension and/or hyperlipidemia are accepted)
Who cannot join
- Part 1:
- History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years
- History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
- History of cancer
- Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
- Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
Show all 24Show fewer
- History of asthma, severe wheezing, COPD, or other pulmonary disease
- Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
- Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days
- Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
- Nitrate therapy within 4 weeks
- History of significant drug allergy or history of food allergies
- Part 2
- History of any clinically significant cardiac or cardiovascular disease (other than hypertension)
- History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
- History of cancer
- History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
- Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
- History of asthma, severe wheezing, COPD, or other pulmonary disease
- Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
- Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
- Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days
- Nitrate therapy within 4 weeks
- History of significant drug allergy
About this study
Official title: A Double-Blind, Double Dummy, Randomized, Placebo-Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of MK1809 in Healthy Young Volunteers
The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan.
- Conditions
- Hypertension
- Being tested
- MK1809, Comparator: Losartan, Comparator: Placebo
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK1809Drug
single oral doses of MK1809
Comparator: LosartanDrug
Also called Losartan
single oral doses of 100 mg Losartan
Comparator: PlaceboDrug
Placebo to MK1809
| Study group | Role | What they receive |
|---|---|---|
| Part 1 A-1 | Experimental | Part 1; Panel A; Sequence 1:
2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 A-2 | Experimental | Part 1; Panel A; Sequence 2:
Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809 Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 A-3 | Experimental | Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809 Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 A-4 | Experimental | Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 A-5 | Experimental | Part 1; Panel A; Sequence 5:
Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809 Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 B-1 | Experimental | Part 1; Panel B; Sequence 1:
5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food Receives: Drug: MK1809; Drug: Comparator: Placebo |
| Part 1 B-2 | Experimental | Part 1; Panel B; Sequence 2:
5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 B-3 | Experimental | Part 1; Panel B; Sequence 3:
5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food Receives: Drug: MK1809; Drug: Comparator: Losartan |
| Part 1 B-4 | Experimental | Part 1; Panel B; Sequence 4:
Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 1 B-5 | Experimental | Part 1; Panel B; Sequence 5:
Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 2 C-1 | Experimental | Part 2; Panel C; Sequence 1:
50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 2 C-2 | Experimental | Part 2; Panel C; Sequence 2:
50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809 Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 2 C-3 | Experimental | Part 2; Panel C; Sequence 3:
Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 2 C-4 | Experimental | Part 2; Panel C; Sequence 4:
50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809 Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
| Part 2 C-5 | Experimental | Part 2; Panel C; Sequence 5:
Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809 Receives: Drug: MK1809; Drug: Comparator: Losartan; Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state
Measured: Through 32 hours postdose
Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state
Measured: 24 hours postdose
Part 2: Safety and tolerability of rising single oral doses of MK1809 in adult hypertensive patients based on an assessment of clinical and laboratory adverse experiences
Measured: Duration of study and up to 14 days after administration of the last dose of study drug
Secondary outcomes (5)
Part 1: Area under the plasma concentration (AUC) versus time curve resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
Measured: 24 hours postdose
Part 1: Maximum concentration of drug in the plasma (Cmax) resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
Measured: Through 32 hours postdose
Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability
Measured: Duration of study and up to 14 days after administration of the last dose of study drug
Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite
Measured: Through 32 hours postdose
Part 2: Trough plasma concentration of the E3174 metabolite
Measured: Through 32 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study start11 Sep 2007
- Primary completion19 Jun 2008
- Study completion19 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033318
- Sponsor's protocol ID
- 1809-001
- Other IDs
- MK1809-001, 2009_703
- Status last verified
- Sep 2018
- First submitted
- 15 Dec 2009
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double Dummy, Randomized, Placebo-Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of MK1809 in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT01033318
- Acronym / sponsor ID
- 1809-001
- Conditions
- Hypertension
- Keywords
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2007 (actual)
- Primary completion
- 19 Jun 2008 (actual)
- Study completion
- 19 Jun 2008 (actual)
- First posted
- 16 Dec 2009 (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.
The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Part 1 A-1 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel A; Sequence 1: 2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan |
| Part 1 A-2 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel A; Sequence 2: Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809 |
| Part 1 A-3 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809 |
| Part 1 A-4 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo |
| Part 1 A-5 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel A; Sequence 5: Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809 |
| Part 1 B-1 | Experimental | Drug: MK1809, Drug: Comparator: PlaceboPart 1; Panel B; Sequence 1: 5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food |
| Part 1 B-2 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel B; Sequence 2: 5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food |
| Part 1 B-3 | Experimental | Drug: MK1809, Drug: Comparator: LosartanPart 1; Panel B; Sequence 3: 5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food |
| Part 1 B-4 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel B; Sequence 4: Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food |
| Part 1 B-5 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 1; Panel B; Sequence 5: Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food |
| Part 2 C-1 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 2; Panel C; Sequence 1: 50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan |
| Part 2 C-2 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 2; Panel C; Sequence 2: 50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809 |
| Part 2 C-3 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 2; Panel C; Sequence 3: Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo |
| Part 2 C-4 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 2; Panel C; Sequence 4: 50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809 |
| Part 2 C-5 | Experimental | Drug: MK1809, Drug: Comparator: Losartan, Drug: Comparator: PlaceboPart 2; Panel C; Sequence 5: Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Nonsmoker for at least 6 months
- Body Mass Index (BMI) less than or equal to 29 kg/m2
- In overall good health
- Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2
- In overall good health (patients with hypertension and/or hyperlipidemia are accepted)
Key exclusion criteria (24 listed)
- History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years
- History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
- History of cancer
- Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
- Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
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 |
|---|---|---|
| MK1809single oral doses of MK1809 | Drug | Part 1 A-1, Part 1 A-2, Part 1 A-3, Part 1 A-4, Part 1 A-5, Part 1 B-1, Part 1 B-2, Part 1 B-3, Part 1 B-4, Part 1 B-5, Part 2 C-1, Part 2 C-2, Part 2 C-3, Part 2 C-4, Part 2 C-5 |
| Comparator: LosartanAlso: Losartansingle oral doses of 100 mg Losartan | Drug | Part 1 A-1, Part 1 A-2, Part 1 A-3, Part 1 A-4, Part 1 A-5, Part 1 B-2, Part 1 B-3, Part 1 B-4, Part 1 B-5, Part 2 C-1, Part 2 C-2, Part 2 C-3, Part 2 C-4, Part 2 C-5 |
| Comparator: PlaceboPlacebo to MK1809 | Drug | Part 1 A-1, Part 1 A-2, Part 1 A-3, Part 1 A-4, Part 1 A-5, Part 1 B-1, Part 1 B-2, Part 1 B-4, Part 1 B-5, Part 2 C-1, Part 2 C-2, Part 2 C-3, Part 2 C-4, Part 2 C-5 |
Primary outcome
Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state
Time frame: Through 32 hours postdose
Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state
Time frame: 24 hours postdose
Part 2: Safety and tolerability of rising single oral doses of MK1809 in adult hypertensive patients based on an assessment of clinical and laboratory adverse experiences
Time frame: Duration of study and up to 14 days after administration of the last dose of study drug
5 secondary outcomes
Part 1: Area under the plasma concentration (AUC) versus time curve resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
Time frame: 24 hours postdose
Part 1: Maximum concentration of drug in the plasma (Cmax) resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
Time frame: Through 32 hours postdose
Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability
Time frame: Duration of study and up to 14 days after administration of the last dose of study drug
Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite
Time frame: Through 32 hours postdose
Part 2: Trough plasma concentration of the E3174 metabolite
Time frame: Through 32 hours postdose
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 26 Sep 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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK1809 and Comparator: Losartan in people with Hypertension, run by Merck Sharp & Dohme LLC.
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 24 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 26 Sep 2018. 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. 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?
Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state (time frame: Through 32 hours postdose). The study lists 3 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 26 Sep 2018.