Trial Outcomes & Findings for A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate (NCT NCT05160363)
NCT ID: NCT05160363
Last Updated: 2024-05-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
From start of IP administration - to follow up visit, Day 30
Results posted on
2024-05-10
Participant Flow
37 participants of the expected 40 participants were enrolled at a Phase 1 Pharmacology Unit in London, UK. The first volunteer was enrolled on 14Feb2022. A total of 87 volunteers were screened, ultimately 37 participants were dosed.
Participant milestones
| Measure |
PYR and PQP Combination
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
|
PYR and Placebo Combination
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Matched placebo for piperaquine (3 or 4 tablets based on body weight)
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
PQP and Placebo Combination
Single dose in the morning on Days 1, 2 and 3 of the study Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg Matched placebo for pyronaridine (3 or 4 tablets based on body weight)
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
Placebo Combination
Single dose in the morning on Days 1, 2 and 3 of the study Matched placebo for pyronaridine (3 or 4 tablets dependent on body weight) and matched placebo piperaquine (3 or 4 tablets dependent on body weight)
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
15
|
8
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate
Baseline characteristics by cohort
| Measure |
PYR and PQP Combination
n=15 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
|
PYR and Placebo Combination
n=8 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Matched placebo for piperaquine (3 or 4 tablets based on body weight)
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
PQP and Placebo Combination
n=8 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg Matched placebo for pyronaridine (3 or 4 tablets based on body weight)
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
Placebo Combination
n=6 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Matched placebo for pyronaridine (3 or 4 tablets dependent on body weight) and matched placebo piperaquine (3 or 4 tablets dependent on body weight)
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
27 Years
n=5 Participants
|
30.5 Years
n=7 Participants
|
27.9 Years
n=5 Participants
|
26 Years
n=4 Participants
|
27.8 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Sub-Saharan African origin
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From start of IP administration - to follow up visit, Day 30Population: Participants
Outcome measures
| Measure |
PYR and PQP Combination
n=15 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
|
PYR and Placebo Combination
n=8 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Matched placebo for piperaquine (3 or 4 tablets based on body weight)
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
PQP and Placebo Combination
n=8 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg Matched placebo for pyronaridine (3 or 4 tablets based on body weight)
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
Placebo Combination
n=6 Participants
Single dose in the morning on Days 1, 2 and 3 of the study Matched placebo for pyronaridine (3 or 4 tablets dependent on body weight) and matched placebo piperaquine (3 or 4 tablets dependent on body weight)
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
|---|---|---|---|---|
|
The Incidence, Severity and Relationship of Treatment-Emergent Adverse Events (TEAEs).
number of participants with at least one Related TEAE
|
5 participants
|
5 participants
|
2 participants
|
0 participants
|
|
The Incidence, Severity and Relationship of Treatment-Emergent Adverse Events (TEAEs).
number of participants with at least one TEAE
|
10 participants
|
7 participants
|
4 participants
|
5 participants
|
|
The Incidence, Severity and Relationship of Treatment-Emergent Adverse Events (TEAEs).
number of participants with at least one Mild TEAE
|
9 participants
|
6 participants
|
4 participants
|
5 participants
|
|
The Incidence, Severity and Relationship of Treatment-Emergent Adverse Events (TEAEs).
number of participants with at least one Moderate TEAE
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Incidence, Severity and Relationship of Treatment-Emergent Adverse Events (TEAEs).
number of participants with at least one Severe TEAE
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
PYR and PQP Combination
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
PYR and Placebo Combination
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PQP and Placebo Combination
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Combination
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PYR and PQP Combination
n=15 participants at risk
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
|
PYR and Placebo Combination
n=8 participants at risk
Single dose in the morning on Days 1, 2 and 3 of the study Pyronaridine tetraphosphate 540 mg (three tablets) if body weight 50kg - \<65kg; OR, 720 mg (4 tablets) if body weight is ≥65 kg Matched placebo for piperaquine (3 or 4 tablets based on body weight)
Pyronaridine Tetraphosphate: A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
PQP and Placebo Combination
n=8 participants at risk
Single dose in the morning on Days 1, 2 and 3 of the study Piperaquine tetraphosphate 960 mg (three tablets) if body weight 50kg - \<75kg; OR, 1280 mg (4 tablets) if body weight ≥75kg Matched placebo for pyronaridine (3 or 4 tablets based on body weight)
Piperaquine tetraphosphate: A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
Placebo Combination
n=6 participants at risk
Single dose in the morning on Days 1, 2 and 3 of the study Matched placebo for pyronaridine (3 or 4 tablets dependent on body weight) and matched placebo piperaquine (3 or 4 tablets dependent on body weight)
Placebo: Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Cardiac disorders
Postural Dizziness
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
16.7%
1/6 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Cardiac disorders
Presyncope
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
16.7%
1/6 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
|
Eye disorders
Visual Impairment
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Change of Bowel Habit
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
25.0%
2/8 • Number of events 2 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 2 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
16.7%
1/6 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
20.0%
3/15 • Number of events 3 • From start of IP administration to follow-up visit at Day 30
|
25.0%
2/8 • Number of events 2 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
16.7%
1/6 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
16.7%
1/6 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Infections and infestations
Systemic Viral Infection
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
25.0%
2/8 • Number of events 2 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Musculoskeletal and connective tissue disorders
Musculokeletal Chest Pain
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
50.0%
3/6 • Number of events 3 • From start of IP administration to follow-up visit at Day 30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
16.7%
1/6 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Vascular disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/15 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/8 • From start of IP administration to follow-up visit at Day 30
|
12.5%
1/8 • Number of events 1 • From start of IP administration to follow-up visit at Day 30
|
0.00%
0/6 • From start of IP administration to follow-up visit at Day 30
|
Additional Information
Senior Director, Program Leadership and Strategy
Medicines for Malaria
Phone: +41 22 555 03 26
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If the Sponsor and RPL agree that it will be desirable to publish the results of this trial; both parties will liaise in good faith to publish the results. RPL agree to obtain the Sponsor's prior written approval of such publications.
- Publication restrictions are in place
Restriction type: OTHER