MalariaPhase 1NCT02885506
A FIH Study to Investigate the Safety, Tolerability and PK of P218
A Phase 1 study testing Oral administration of P218 capsules in people with Malaria, run by Medicines for Malaria Venture at 1 site in United Kingdom.
Trial summary
The First in Human (FIH) study is separated into two parts: The first part is a Single Ascending Dose (SAD), double-blinded, randomized and placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Oral administration of P218 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2016to 4 Dec 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy male or female (of non-childbearing potential), aged 18 to 45 years, inclusive.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECG), and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
- Subject has a body weight of at least 50 kg and a Body Mass Index (BMI) of 18-25 Kg/m2, inclusive.
- Female subjects must be of non-childbearing potential:
- Natural (spontaneous) post-menopausal defined as being amenorrheic for at least 12 months without an alternative medical cause with a screening follicle stimulating hormone level > 25 IU/L (or at the local laboratory levels for post-menopause).
- Premenopausal with irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy or salpingectomy at least 6 months before screening (as determined by subject medical history).
Show all 22Show fewer
- Heterosexually active male subjects with a female spouse/partner of childbearing potential must agree to use barrier contraception (male condom), even with documented medical assessment of surgical success of a vasectomy, if your partner could become pregnant from the time of the first administration of P218 and for 100 days following this. Your partner must also use a method of highly effective contraception including:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Subjects are non-smokers or ex-smokers for more than 90 days prior to screening or smoke no more than 5 cigarettes per day. If users of nicotine products (i.e. spray, patch, e-cigarette, etc.) no more than 5 cigarettes per day is allowed. Subjects must agree to abstain from smoking while in the unit.
- Ability to swallow multiple capsules at a time or (consecutively) 1 capsule at a time.
- Subjects must be capable of fully understanding and complying with the requirements of the study and must have signed the informed consent form prior to undergoing any study-related procedures.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Male subjects with a female partner(s) who is (are) pregnant or lactating from the time of the administration of study medication.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including gallbladder), cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug or food allergies, anaphylaxis or other severe allergic reactions but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- Any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion.
- Any history of gallbladder disease, including cholecystitis and/or cholelithiasis.
Show all 31Show fewer
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of the participation in the study may influence the result of the study, or the subject's ability to participate in the study.
- History of photosensitivity.
- History of megaloblastic anaemia or folate deficiency.
- History or clinical evidence of substance and/or alcohol abuse within the 12 months before screening. Alcohol abuse is defined as regular weekly intake of more than 21 units for males and 14 units for females (using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx).
- Treatment with an investigational drug within 90 days or 5 half-lives preceding the first dose of study medication (or as determined by the local requirement, whichever is the longer).
- Donation of blood or blood products (excluding plasma) within 90 days prior to study medication administration.
- Use of moderate/strong inhibitors or inducers of Cytochromes P450 (CYP450) or transporters within 30 days or 5 half-lives (whichever is the longer) prior to the first dose of study medication.
- Consumption of grapefruit, grapefruit juice or grapefruit-related citrus fruits (e.g. Seville oranges, pomelos) within 30 days prior to the first dose of study medication.
- Ingestion of any poppy seeds within the 24 hours prior to screening.
- Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is the longer) prior to the first dose of study medication. With the exception of paracetamol, which may be used incidentally or for a short-term treatment at a maximum dose of 1 gr. per day.
- Use of herbal supplements at least 30 days prior to the first dose of study medication.
- Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
- The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise related clinically significant cardiac events.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of corrected QT interval (QTc) changes. This includes subjects with any of the following (at screening):
- Sinus node dysfunction.
- Clinically significant interval prolongation of the interval from the beginning of the P wave to the beginning of the three distinct waves created by the passage of the cardiac electrical impulse through the ventricles (QRS complex) on an electrocardiogram (PR).
- Intermittent second or third degree atrioventricular (AV) block.
- Incomplete or complete bundle branch block.
- Abnormal T wave morphology.
- Prolonged QT intervals calculated using Bazett's formula (QTcB) >450 ms or shortened QTcB < 350 ms. Any other ECG abnormalities in the standard 12-lead ECG and 24-hour 12 lead Holter ECG or an equivalent assessment which in the opinion of the Investigator will interfere with the ECG analysis.
- Subjects with borderline abnormalities may be included if the deviations do not pose a safety risk, and if agreed between the appointed Cardiologist and the PI.
- Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, and methadone) or from the alcohol breath test at screening or on admission.
- A positive human immunodeficiency virus (HIV) I and II antibodies, hepatitis B surface antigen (HBsAg), anti Hepatitis core antibody (anti hepatitis B core antigen (HBc) immunoglobulin G (IgG) [and anti HBc Immunoglobulin M (IgM) if IgG is positive]), or hepatitis C virus (HCV) antibody at screening.
- Subjects have veins unsuitable for intravenous puncture or cannulation on either arm (e.g. veins that are difficult to locate access or puncture veins with a tendency to rupture during or after puncture).
- Any conditions which in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subjects' participation in or completion of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology Ltd
Croydon, Surrey, CR7 7YE
About this study
Official title: A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile and Food Effect of P218 in Healthy Adult Volunteers
The First in Human (FIH) study is separated into two parts:
- The first part is a Single Ascending Dose (SAD), double-blinded, randomized and placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).
- The second part is a food effect cohort with an open-labelled, randomized fed/fasted cross-over design.
The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics (PK) of P218 in healthy volunteers.
Read the detailed description
The study is divided into two parts:
Part A
This is a double-blind randomised, placebo-controlled, parallel group, ascending dose study and will comprise up to eight fasted cohorts (8 volunteers in each) that will receive a single ascending dose (SAD) of P218 to assess its safety, tolerability and pharmacokinetic profile. Each subject will participate in only one dose group and will receive only one dose of study drug. In each cohort, 2 and 6 subjects will be randomized to placebo and P218, respectively. The data obtained from each cohort will undergo a formal review by the Safety Review Team (SRT). SRT will confirm that it is safe to proceed with the next dose/cohort.
Part B
This is the pilot food effect evaluation. Once predicted human efficacious concentrations of P218 and a safe exposure window (at least 3-fold above the targeted therapeutic exposure in order to account for a possible increase in exposure with food) has been achieved in Part A, a new cohort of 8 subjects (all receiving active drug) will be evaluated for food effect in an open-label, randomized fed/fasted crossover design. Subjects participating in this food effect cohort will be randomized to two single dose sessions (fed/fasted). The second dose will be administered after a washout period of at least 5x observed human half-life (T1/2), to be confirmed once PK data are available from the relevant doses from Part A.
Primary objectives:
- To investigate the safety and tolerability of single escalating oral doses of P218 when administered to healthy volunteers (men and Women of Non Child Bearing Potential (WNCBP)) under fasted conditions.
Secondary objectives:
- To describe the pharmacokinetics of P218 and its major glucuronide metabolite (P218 acyl glucuronide) in healthy volunteers (men and WNCBP) after administration of single escalating oral doses
- To investigate the effect of a high fat meal on the pharmacokinetics and safety/tolerability of P218.
This study incorporates the use of an adaptive design. All anticipated dosing levels can be adjusted in accordance with PK, safety and tolerability data collected up to the decision making time-point.
- Conditions
- Malaria
- Being tested
- Oral administration of P218 capsules, Oral administration of P218 matching placebo
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of P218 capsulesDrug
Oral administration of P218 capsules. The number of capsules is determined by the dose level of the cohort.
Oral administration of P218 matching placeboDrug
Oral administration of P218 matching placebo. The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Oral administration of P218 capsules 10 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 2 | Experimental | Oral administration of P218 capsules 30 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 3 | Experimental | Oral administration of P218 capsules 100 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 4 | Experimental | Oral administration of P218 capsules 250 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 5 | Experimental | Oral administration of P218 capsules 500 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 6 | Experimental | Oral administration of P218 capsules 750 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 7 | Experimental | Oral administration of P218 capsules 1000 mg Receives: Drug: Oral administration of P218 capsules |
| Cohort 8 - Pooled Placebo | Placebo comparator | Oral administration of P218 matching placebo Receives: Drug: Oral administration of P218 matching placebo |
| Fed - Fasted | Experimental | Oral administration of P218 capsules 250 mg Under fed then fasted conditions. Receives: Drug: Oral administration of P218 capsules |
| Fasted - Fed | Experimental | Oral administration of P218 capsules 250 mg Under fasted then fed conditions. Receives: Drug: Oral administration of P218 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of P218: Incidence, Severity and Relationship to the Investigational Product of Observed and Self-reported Adverse Events
Number of participants with adverse events
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Secondary outcomes (7)
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: AUClast
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: AUCinf
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Maximum Plasma Drug Concentration (Cmax)
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Cmax
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax)
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Tmax
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Elimination Half-life (t1/2)
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: t1/2
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) (for Parent Only)
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: CL/F (for parent only)
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Apparent Volume of Distribution During Terminal Phase After Oral Administration (Vz/F) (for Parent Only).
Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Vz/F (for parent only).
Measured: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start24 Aug 2016
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalariaStudies 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
- Sequential
- Model description
- Part A of the study was conducted as a dose escalation, and that Part B utilized a cross-over design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Emilie Rossignol, PhD, Study director, Medicines for Malaria Venture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885506
- Sponsor's protocol ID
- MMV_P218_15_01
- Other IDs
- 2016-001933-29, 2016
- Status last verified
- May 2019
- First submitted
- 19 Aug 2016
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile and Food Effect of P218 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02885506
- Acronym / sponsor ID
- MMV_P218_15_01
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Richmond Pharmacology Limited
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The First in Human (FIH) study is separated into two parts:
- The first part is a Single Ascending Dose (SAD), double-blinded, randomized and placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).
- The second part is a food effect cohort with an open-labelled, randomized fed/fasted cross-over design.
The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics (PK) of P218 in healthy volunteers.
Detailed description
The study is divided into two parts:
Part A
This is a double-blind randomised, placebo-controlled, parallel group, ascending dose study and will comprise up to eight fasted cohorts (8 volunteers in each) that will receive a single ascending dose (SAD) of P218 to assess its safety, tolerability and pharmacokinetic profile. Each subject will participate in only one dose group and will receive only one dose of study drug. In each cohort, 2 and 6 subjects will be randomized to placebo and P218, respectively. The data obtained from each cohort will undergo a formal review by the Safety Review Team (SRT). SRT will confirm that it is safe to proceed with the next dose/cohort.
Part B
This is the pilot food effect evaluation. Once predicted human efficacious concentrations of P218 and a safe exposure window (at least 3-fold above the targeted therapeutic exposure in order to account for a possible increase in exposure with food) has been achieved in Part A, a new cohort of 8 subjects (all receiving active drug) will be evaluated for food effect in an open-label, randomized fed/fasted crossover design. Subjects participating in this food effect cohort will be randomized to two single dose sessions (fed/fasted). The second dose will be administered after a washout period of at least 5x observed human half-life (T1/2), to be confirmed once PK data are available from the relevant doses from Part A.
Primary objectives:
- To investigate the safety and tolerability of single escalating oral doses of P218 when administered to healthy volunteers (men and Women of Non Child Bearing Potential (WNCBP)) under fasted conditions.
Secondary objectives:
- To describe the pharmacokinetics of P218 and its major glucuronide metabolite (P218 acyl glucuronide) in healthy volunteers (men and WNCBP) after administration of single escalating oral doses
- To investigate the effect of a high fat meal on the pharmacokinetics and safety/tolerability of P218.
This study incorporates the use of an adaptive design. All anticipated dosing levels can be adjusted in accordance with PK, safety and tolerability data collected up to the decision making time-point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
- Model description
- Part A of the study was conducted as a dose escalation, and that Part B utilized a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 10 mg |
| Cohort 2 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 30 mg |
| Cohort 3 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 100 mg |
| Cohort 4 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 250 mg |
| Cohort 5 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 500 mg |
| Cohort 6 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 750 mg |
| Cohort 7 | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 1000 mg |
| Cohort 8 - Pooled Placebo | Placebo comparator | Drug: Oral administration of P218 matching placeboOral administration of P218 matching placebo |
| Fed - Fasted | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 250 mg Under fed then fasted conditions. |
| Fasted - Fed | Experimental | Drug: Oral administration of P218 capsulesOral administration of P218 capsules 250 mg Under fasted then fed conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Subject is a healthy male or female (of non-childbearing potential), aged 18 to 45 years, inclusive.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECG), and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
- Subject has a body weight of at least 50 kg and a Body Mass Index (BMI) of 18-25 Kg/m2, inclusive.
- Female subjects must be of non-childbearing potential:
- Heterosexually active male subjects with a female spouse/partner of childbearing potential must agree to use barrier contraception (male condom), even with documented medical assessment of surgical success of a vasectomy, if your partner could become pregnant from the time of the first administration of P218 and for 100 days following this. Your partner must also use a method of highly effective contraception including:
Key exclusion criteria (31 listed)
- Male subjects with a female partner(s) who is (are) pregnant or lactating from the time of the administration of study medication.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including gallbladder), cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug or food allergies, anaphylaxis or other severe allergic reactions but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- Any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion.
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 |
|---|---|---|
| Oral administration of P218 capsulesOral administration of P218 capsules. The number of capsules is determined by the dose level of the cohort. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Fasted - Fed, Fed - Fasted |
| Oral administration of P218 matching placeboOral administration of P218 matching placebo. The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug. | Drug | Cohort 8 - Pooled Placebo |
Primary outcome
Safety and Tolerability of P218: Incidence, Severity and Relationship to the Investigational Product of Observed and Self-reported Adverse Events
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Number of participants with adverse events
7 secondary outcomes
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Maximum Plasma Drug Concentration (Cmax)
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax)
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Elimination Half-life (t1/2)
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) (for Parent Only)
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Apparent Volume of Distribution During Terminal Phase After Oral Administration (Vz/F) (for Parent Only).
Time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Emilie Rossignol, PhD study director
Medicines for Malaria Venture
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 Oral administration of P218 capsules in people with Malaria, run by Medicines for Malaria Venture 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 22 inclusion and 31 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 1 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 P218: Incidence, Severity and Relationship to the Investigational Product of Observed and Self-reported Adverse Events (time frame: During 11 days post administration of a single oral dose of P218 to healthy volunteers). 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 1 Aug 2019.