MalariaPhase 1NCT02230579
Phase I Study of Ascending Doses of MMV390048 in Healthy Adult Volunteers
A Phase 1 study testing MMV390048 5mg, MMV390048 20mg and MMV390048 40mg in people with Malaria, run by Medicines for Malaria Venture at 1 site in South Africa.
Trial summary
This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when administered to healthy male volunteers and female volunteers of non-childbearing potential. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- MMV390048 5mg, MMV390048 20mg and MMV390048 40mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2014to Feb 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- written informed consent
- Male and female (of non-childbearing potential); age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Hematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant. AST, ALT, lactate dehydrogenase, total bilirubin, haptoglobin and hemoglobin must be within the normal reference ranges
- Body weight at least 50kg and body mass index within 18 to 32kg/m2
- Good peripheral venous access
- Able to communicate well with the investigator, to understand and comply with the requirements of the study
- Agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to move away from the study area for the duration of the study
Who cannot join
- Any acute illness upon admission to the unit on Day -1 or prior to dosing on Day 1
- Use of any other investigational drug within 30 days or five half-lives (whichever is longer) prior to the first dose of MMV390048
- history of hypersensitivity to any drugs
- history of anaphylaxis or severe allergic reaction
- Resting vital signs at either screening or baseline outside the defined ranges
- Orthostatic changes in blood pressure and heart rate measurements greater than: 20 mmHg drop in systolic blood pressure; 10 mmHg drop in diastolic blood pressure; 20 beats per minute increase in heart rate
Show all 33Show fewer
- history of clinically significant ECG abnormalities, or any of the defined ECG abnormalities at either screening or baseline
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- males physiologically capable of conceiving offspring UNLESS the volunteer agrees to use condoms and ensure that his partner(s) is either not of child-bearing potential or uses a highly effective method of contraception for the entire duration of the study and for twelve weeks following the last study drug administration
- Smokers (use of tobacco products in the previous three months)
- Use of any prescription drugs, herbal supplements, over--the--counter medication or dietary supplements (vitamins included) within four weeks prior to initial dosing
- Intake of grapefruit, grapefruit juice or other products containing grapefruit within 28 days of the first drug administration of the study drug
- Excessive intake of caffeine drinks or energy drinks within 48 hours before admission defined as more than three 250 ml cups of coffee a day
- Donation or loss of 400 ml or more of blood within eight weeks prior to screening or initial dosing
- Plasma donation (>100 ml) within 60 days prior to first dosing
- Hemoglobin levels below 12.5 g/dl (males) or 11.5 g/dl (females) at screening
- Haptoglobin levels outside the reference range
- Positive direct anti-globulin test
- Liver enzymes other than ALT, AST and lactate dehydrogenase elevated ≥1.5 x ULN within two weeks prior to initial dosing
- history of autonomic dysfunction within 3 years and/or recurrent history
- History of immunodeficiency diseases, including a confirmed positive HIV test result
- Positive Hepatitis B surface antigen or Hepatitis C antibody test result
- History of recurrent infection
- history of endocrine disease, in particular adrenal disorders such as Cushing's syndrome or Addison's disease, or diabetes mellitus
- history of Gilbert's Syndrome
- history of photosensitivity
- history of any food allergy
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardise the safety of the volunteer or the objectives of the study
- History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or urea values, or abnormal urinary constituents
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the tests and laboratory assays at screening and/or baseline
- Any clinically significant mental disorder that could limit the validity of informed consent or the volunteer's ability to comply with protocol requirements
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Cinical Pharmacology, University of Cape Town
Cape Town
About this study
Official title: A Single Centre, Two-part, Double-blind, Randomized, Placebo-controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of MMV390048 in Healthy Adult Volunteers
This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when administered to healthy male volunteers and female volunteers of non-childbearing potential.
In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be investigated.
Read the detailed description
The study is a single centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy male and female volunteers (of non-childbearing potential) aged 18 to 55 years.
The study will be divided into two parts. The first part will comprise up to seven fasted cohorts (8 to 10 volunteers in each) that will receive a single, ascending dose (SAD) of MMV390048 to assess its safety, tolerability and pharmacokinetic profile. The starting dose administered to the first cohort will be 5 mg. An additional cohort (cohort 8, re-using volunteers from one of the previous cohorts) will receive a single dose of MMV390048 in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability of the compound.
The data obtained from each cohort during the SAD part of the study will undergo a formal review by the Safety Review Team (SRT). Should the safety profile of the compound be deemed acceptable, and the pharmacokinetic parameters indicate that acceptable levels of the drug to elicit a pharmacodynamic response can be achieved in human plasma, the study will then proceed to the second part.
During the second part of the study volunteers will receive multiple, ascending doses (MAD) of MMV390048 to assess the pharmacokinetics, safety and tolerability following multiple oral doses. Up to three cohorts of eight volunteers each will be enrolled into this part of the study. Each volunteer will receive three consecutive daily doses of MMV390048.
- Conditions
- Malaria
- Being tested
- MMV390048 5mg, MMV390048 20mg, MMV390048 40mg, MMV390048 80mg, MMV390048 120mg
- Keywords
- safety, tolerability, malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMV390048 5mgDrug
Also called MMV390048
Supplied as "powder in bottle" formulation for reconstitution pre-dose
MMV390048 20mgDrug
Also called MMV390048
Supplied as "powder in bottle" formulation for reconstitution pre-dose.
MMV390048 40mgDrug
Also called MMV390048
Supplied as "powder in bottle" formulation for reconstitution pre-dose
MMV390048 80mgDrug
Also called MMV390048
Supplied as "powder in bottle" formulation for reconstitution pre-dose
MMV390048 120mgDrug
Also called MMV390048
Supplied as "powder in bottle" formulation for reconstitution pre-dose
Placebo to match MMV390048Drug
Also called Placebo
Supplied as "powder in bottle" formulation for reconstitution pre-dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort SAD1 Fasted | Experimental | Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state Receives: Drug: MMV390048 5mg; Drug: Placebo to match MMV390048 |
| Cohort SAD2 Fasted | Experimental | Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state Receives: Drug: MMV390048 20mg; Drug: Placebo to match MMV390048 |
| Cohort SAD3 Fasted | Experimental | Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state Receives: Drug: MMV390048 40mg; Drug: Placebo to match MMV390048 |
| Cohort SAD4 Fasted | Experimental | Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state Receives: Drug: MMV390048 80mg; Drug: Placebo to match MMV390048 |
| Cohort SAD5 Fasted | Experimental | Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state Receives: Drug: MMV390048 120mg; Drug: Placebo to match MMV390048 |
| Cohort SAD6 Fed | Experimental | Cohort SAD6, reusing volunteers from one of the previous cohorts, will receive a single dose in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability Receives: Drug: MMV390048 40mg; Drug: Placebo to match MMV390048 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Subject will be in-house up to D3, and then have a follow up visit at the site on D5, 7, 10, 14, 19, 26, 29 or longer according to half life
Measured: up to D29 or longer according to half life
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMV390048
Pk blood collection - additional PK point may be planned final visit depending on emerging PK data, unnecessary PK points could be eliminated for the latter cohorts Investigate the effect of food on the pharmacokinetic and tolerability of the investigational drug in cohort 4 and 8
Measured: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216, 312, 432, 600, 672 hours post-dose
Half-life of MMV390048
Pk blood collection Investigate the effect of food on the pharmacokinetic and tolerability of the investigational drug in cohort 4 and 8
Measured: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216, 312, 432, 600, 672 hours post-dose
Secondary outcomes (1)
Determine ex Vivo Efficacy (IC50)
Blood collection to determine efficacy of investigational drug against parasites using an ex vivo malaria assay - this was done only for cohort 3 The experimentally obtained bioassay IC50 values were determined and compared to IC50 obtained with reference serum sample spiked with a known amount of MMV390048 titrated into the P. falciparum assay.
Measured: up to 144 hr post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Karen Barnes, Prof, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230579
- Sponsor's protocol ID
- MMV_MMV390048_14_01
- Status last verified
- Feb 2018
- First submitted
- 29 Aug 2014
- Last updated
- 17 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sinxadi P, Donini C, Johnstone H, Langdon G, Wiesner L, Allen E, Duparc S, Chalon S, McCarthy JS, Lorch U, Chibale K, Mohrle J, Barnes KI. Safety, Tolerability, Pharmacokinetics, and Antimalarial Activity of the Novel Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048 in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e01896-19. doi: 10.1128/AAC.01896-19. Print 2020 Mar 24.
PubMed 31932368
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Two-part, Double-blind, Randomized, Placebo-controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of MMV390048 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02230579
- Acronym / sponsor ID
- MMV_MMV390048_14_01
- Conditions
- Malaria
- Keywords
- safety, tolerability, malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 29 Oct 2018
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 first-in-human study of MMV390048. The study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when administered to healthy male volunteers and female volunteers of non-childbearing potential.
In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be investigated.
Detailed description
The study is a single centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy male and female volunteers (of non-childbearing potential) aged 18 to 55 years.
The study will be divided into two parts. The first part will comprise up to seven fasted cohorts (8 to 10 volunteers in each) that will receive a single, ascending dose (SAD) of MMV390048 to assess its safety, tolerability and pharmacokinetic profile. The starting dose administered to the first cohort will be 5 mg. An additional cohort (cohort 8, re-using volunteers from one of the previous cohorts) will receive a single dose of MMV390048 in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability of the compound.
The data obtained from each cohort during the SAD part of the study will undergo a formal review by the Safety Review Team (SRT). Should the safety profile of the compound be deemed acceptable, and the pharmacokinetic parameters indicate that acceptable levels of the drug to elicit a pharmacodynamic response can be achieved in human plasma, the study will then proceed to the second part.
During the second part of the study volunteers will receive multiple, ascending doses (MAD) of MMV390048 to assess the pharmacokinetics, safety and tolerability following multiple oral doses. Up to three cohorts of eight volunteers each will be enrolled into this part of the study. Each volunteer will receive three consecutive daily doses of MMV390048.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort SAD1 Fasted | Experimental | Drug: MMV390048 5mg, Drug: Placebo to match MMV390048Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state |
| Cohort SAD2 Fasted | Experimental | Drug: MMV390048 20mg, Drug: Placebo to match MMV390048Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state |
| Cohort SAD3 Fasted | Experimental | Drug: MMV390048 40mg, Drug: Placebo to match MMV390048Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state |
| Cohort SAD4 Fasted | Experimental | Drug: MMV390048 80mg, Drug: Placebo to match MMV390048Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state |
| Cohort SAD5 Fasted | Experimental | Drug: MMV390048 120mg, Drug: Placebo to match MMV390048Five fasted cohorts will receive a single, ascending dose of MMV390048. The starting dose will be 5mg. Cohort SAD6 will receive a single dose in a fed state |
| Cohort SAD6 Fed | Experimental | Drug: MMV390048 40mg, Drug: Placebo to match MMV390048Cohort SAD6, reusing volunteers from one of the previous cohorts, will receive a single dose in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- written informed consent
- Male and female (of non-childbearing potential); age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Hematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant. AST, ALT, lactate dehydrogenase, total bilirubin, haptoglobin and hemoglobin must be within the normal reference ranges
- Body weight at least 50kg and body mass index within 18 to 32kg/m2
- Good peripheral venous access
Key exclusion criteria (33 listed)
- Any acute illness upon admission to the unit on Day -1 or prior to dosing on Day 1
- Use of any other investigational drug within 30 days or five half-lives (whichever is longer) prior to the first dose of MMV390048
- history of hypersensitivity to any drugs
- history of anaphylaxis or severe allergic reaction
- Resting vital signs at either screening or baseline outside the defined ranges
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 |
|---|---|---|
| MMV390048 5mgAlso: MMV390048Supplied as "powder in bottle" formulation for reconstitution pre-dose | Drug | Cohort SAD1 Fasted |
| MMV390048 20mgAlso: MMV390048Supplied as "powder in bottle" formulation for reconstitution pre-dose. | Drug | Cohort SAD2 Fasted |
| MMV390048 40mgAlso: MMV390048Supplied as "powder in bottle" formulation for reconstitution pre-dose | Drug | Cohort SAD3 Fasted, Cohort SAD6 Fed |
| MMV390048 80mgAlso: MMV390048Supplied as "powder in bottle" formulation for reconstitution pre-dose | Drug | Cohort SAD4 Fasted |
| MMV390048 120mgAlso: MMV390048Supplied as "powder in bottle" formulation for reconstitution pre-dose | Drug | Cohort SAD5 Fasted |
| Placebo to match MMV390048Also: PlaceboSupplied as "powder in bottle" formulation for reconstitution pre-dose | Drug | Cohort SAD1 Fasted, Cohort SAD2 Fasted, Cohort SAD3 Fasted, Cohort SAD4 Fasted, Cohort SAD5 Fasted, Cohort SAD6 Fed |
Primary outcome
Number of Participants With Adverse Events
Time frame: up to D29 or longer according to half life
Subject will be in-house up to D3, and then have a follow up visit at the site on D5, 7, 10, 14, 19, 26, 29 or longer according to half life
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMV390048
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216, 312, 432, 600, 672 hours post-dose
Pk blood collection - additional PK point may be planned final visit depending on emerging PK data, unnecessary PK points could be eliminated for the latter cohorts Investigate the effect of food on the pharmacokinetic and tolerability of the investigational drug in cohort 4 and 8
Half-life of MMV390048
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216, 312, 432, 600, 672 hours post-dose
Pk blood collection Investigate the effect of food on the pharmacokinetic and tolerability of the investigational drug in cohort 4 and 8
1 secondary outcome
Determine ex Vivo Efficacy (IC50)
Time frame: up to 144 hr post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31932368Sinxadi P, Donini C, Johnstone H, Langdon G, Wiesner L, Allen E, Duparc S, Chalon S, McCarthy JS, Lorch U, Chibale K, Mohrle J, Barnes KI. Safety, Tolerability, Pharmacokinetics, and Antimalarial Activity of the Novel Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048 in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e01896-19. doi: 10.1128/AAC.01896-19. Print 2020 Mar 24.
- Individual participant dataSharing planned: No
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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.
Karen Barnes, Prof principal investigator
University of Cape Town
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 MMV390048 5mg, MMV390048 20mg and MMV390048 40mg in people with Malaria, run by Medicines for Malaria Venture at 1 site in South Africa.
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 33 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 17 Jul 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 South Africa. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2018). 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?
Number of Participants With Adverse Events (time frame: up to D29 or longer according to half life). 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?
On the ClinicalTrials.gov record for NCT02230579, 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 17 Jul 2019.